Medicament delivery device configured to produce wireless and audible outputs

ABSTRACT

An apparatus includes a simulated medicament delivery device and an electronic circuit system. The simulated medicament delivery device includes a housing, and is devoid of a medicament delivery mechanism that causes a medicament to be delivered. The electronic circuit system is coupled to the housing and includes an audible output device and a cover. The housing of the medicament delivery device and the cover of the electronic circuit system collectively define an acoustic enclosure. The audible output device is configured to be disposed within the acoustic enclosure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 13/234,649, entitled “Simulated Medicament DeliveryDevice Configured to Produce an Audible Output,” filed Sep. 16, 2011,which is a continuation of U.S. patent application Ser. No. 12/180,708,now U.S. Pat. No. 8,021,344, entitled “Medicament Delivery DeviceConfigured to Produce an Audible Output,” filed Jul. 28, 2008, each ofwhich is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to a medical device, and moreparticularly to a medicament delivery device having an electroniccircuit system that produces an audible output.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure. Becauseemergency medical facilities may not be available when an individual issuffering from an allergic reaction, some individuals carry a medicamentdelivery device, such as, for example, an auto-injector, to rapidlyself-administer a medicament in response to an allergic reaction.

To actuate such a medicament delivery device, however, the user may berequired to execute a series of operations. For example, to actuate someknown auto-injectors, the user must remove a protective cap, remove alocking device, place the auto-injector in a proper position against thebody and then press a button to actuate the auto-injector. Failure tocomplete these operations properly can result in an incomplete injectionand/or injection into an undesired location of the body. In certaininstances, for example, users who have become confused in the operationof some known auto-injectors have inadvertently injected the medicamentinto their thumb by improperly positioning the auto-injector.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, and may therefore have no experience with the medicamentdelivery device. Similarly, because some known medicament deliverydevices are configured to be used relatively infrequently in response toan allergic reaction or the like, even those users familiar with thedevice and/or who have been trained may not be well practiced atoperating the device. Finally, such devices are often used during anemergency situation, during which even experienced and/or trained usersmay be subject to confusion, panic, and/or the physiological effects ofthe condition requiring treatment.

Some known medicament delivery devices include printed instructions toinform the user of the steps required to properly deliver themedicament. Such printed instructions, however, can be inadequate forthe class of users and/or the situations described above. Moreover,because some known medicament delivery devices, such as, for example,auto-injectors, pen injectors, inhalers or the like, can be compact,such printed instructions may be too small to read and comprehend duringan emergency situation.

Some known medicament delivery devices can produce sounds, such as abeep or a click, that can be used as prompts to users of medicamentdelivery devices. The sounds of such know devices and the manner inwhich the sounds are produced, however, provide limited information tothe user. For example, some known medicament delivery devices produce asingle tone to indicate that a proper dosage has been set but cannotprovide a user with instructions associated with the use of the device.Moreover, the sound level and/or the quality of the sound produced bysuch known medicament delivery devices is limited by the size,performance, and/or cost associated with the speaker and/or electroniccomponents necessary to produce the sounds.

Thus, a need exists for medicament delivery systems and/or devices thatprovide instructions, messages, information, and/or directions that areeasily understood and/or heard by a user in any type of situation.

SUMMARY

Medicament delivery devices are described herein. In some embodiments,an apparatus includes a medicament delivery device and an electroniccircuit system. The medicament delivery device includes a housing, amedicament container, and a medicament delivery member. The electroniccircuit system is coupled to the housing and includes an audible outputdevice and a cover. The housing of the medicament delivery device andthe cover of the electronic circuit system collectively define anacoustic enclosure. The audible output device is configured to bedisposed within the acoustic enclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a medicament delivery devicehaving an acoustic enclosure, according to an embodiment of theinvention.

FIG. 2 is a schematic illustration of a medicament delivery devicehaving a ported acoustic enclosure, according to an embodiment of theinvention.

FIG. 3 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIGS. 4A and 4B are perspective views of a medicament delivery deviceaccording to an embodiment of the invention, in a first configuration.

FIG. 5 is a front view of the medicament delivery device illustrated inFIGS. 4A and 4B with the cover removed.

FIG. 6 is a back view of the medicament delivery device illustrated inFIGS. 4A and 4B with the cover removed.

FIG. 7 is a front view of a portion of the medicament delivery deviceillustrated in FIGS. 4A and 4B.

FIG. 8 is a perspective view of a portion of the medicament deliverydevice illustrated in FIGS. 4A and 4B.

FIG. 9 is a bottom perspective view of a housing of the medicamentdelivery device illustrated in FIGS. 4A and 4B.

FIG. 10 is a top perspective view of a housing of the medicamentdelivery device illustrated in FIGS. 4A and 4B.

FIG. 11 is a perspective view of a proximal cap of the medicamentdelivery device illustrated in FIGS. 4A and 4B.

FIG. 12 is a front view of a medicament delivery mechanism of themedicament delivery device illustrated in FIGS. 4A and 4B.

FIG. 13 is a back view of an electronic circuit system of the medicamentdelivery device illustrated in FIGS. 4A and 4B.

FIG. 14 is a front view of a portion of the electronic circuit system ofthe medicament delivery device illustrated in FIG. 13.

FIG. 15 is a back view of a printed circuit board of the electroniccircuit system shown in FIG. 14.

FIG. 16 is a schematic illustration of the electronic circuit systemshown in FIG. 13.

FIG. 17 is a side view of the electronic circuit system of themedicament delivery device illustrated in FIG. 13.

FIG. 18 is a front view of a cover of the electronic circuit systemillustrated in FIG. 13.

FIG. 19 is a perspective view of the cover of the electronic circuitsystem illustrated in FIG. 13.

FIG. 20 is a perspective view of a battery clip of the electroniccircuit system illustrated in FIG. 13.

FIG. 20A is a perspective view of a portion of an electronic circuitsystem of the medical injector illustrated in FIGS. 4A and 4B, in afirst configuration.

FIG. 21 is a front view of the medicament delivery device illustrated inFIGS. 4A and 4B in a first configuration showing the electronic circuitsystem.

FIGS. 21A, 21B, and 21C are front views of a portion of the electroniccircuit system of the medical injector labeled as Region Z in FIG. 21 ina first configuration, a second configuration, and a thirdconfiguration, respectively.

FIGS. 22 and 23 are perspective views of a cover of the medicamentdelivery device illustrated in FIGS. 4A and 4B.

FIG. 24 is a perspective view of a safety lock of the medicamentdelivery device illustrated in FIGS. 4A and 4B.

FIG. 24B is a front view of the safety lock of the medical injectorillustrated in FIG. 24A.

FIG. 25 is a bottom view of the safety lock of the medicament deliverydevice illustrated in FIGS. 24A and 24B.

FIG. 26 is a perspective view of a base of the medicament deliverydevice illustrated in FIGS. 4A and 4B.

FIG. 26A is a front view of the base of the medical injector illustratedin FIGS. 4A and 4B.

FIG. 27 is a back view of the medicament delivery device illustrated inFIGS. 4A and 4B in a second configuration.

FIG. 28 is a back view of the medicament delivery device illustrated inFIGS. 4A and 4B in a third configuration.

FIG. 29 is a back view of the medicament delivery device illustrated inFIGS. 4A and 4B in a fourth configuration.

FIG. 30 is a schematic illustration of a medicament delivery device andan electronic circuit system assembly according to an embodiment of theinvention.

FIG. 31 is a schematic illustration of the electronic circuit systemassembly shown in FIG. 30 coupled to the medicament delivery deviceshown in FIG. 30.

FIG. 32 is a cross-sectional view of the electronic circuit systemassembly and the medicament delivery device shown in FIG. 31, takenalong a plane including line X-X.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a medicament delivery deviceand an electronic circuit system. The medicament delivery deviceincludes a housing, a medicament container, and a medicament deliverymember. The medicament container and at least a portion of themedicament delivery member are disposed within the housing. Theelectronic circuit system is coupled to the housing and includes anaudible output device and a cover. The housing of the medicamentdelivery device and the cover of the electronic circuit systemcollectively define an acoustic enclosure. The audible output device,which can be, for example, a speaker, is configured to be disposedwithin the acoustic enclosure.

In some embodiments, an apparatus includes a medicament delivery deviceand an electronic circuit system. The medicament delivery deviceincludes a housing and a medicament container. The medicament containeris disposed within the housing. The electronic circuit system is coupledto the housing and includes a speaker and a cover. The speaker includesa front portion and a back portion. The front portion of the speaker isconfigured to output a first audible output including a first set ofsound waves. The back portion of the speaker is configured to output asecond audible output including a second set of sound waves. The housingof the medicament delivery device defines a first opening through whichthe first set of sound waves is configured to travel. The cover of theelectronic circuit system defines a second opening through which thesecond set of sound waves is configured to travel.

In some embodiments, an apparatus includes a medicament delivery deviceand an electronic circuit system, the medicament delivery deviceincluding a housing, a medicament container, and a medicament deliverymember. The medicament container and at least a portion of themedicament delivery member are disposed within the housing. Theelectronic circuit system is coupled to the housing and includes anaudio processor and an audible output device. The audio processor isconfigured to output an electronic signal associated with recordedspeech to the audible output device via an electronic path devoid of anamplifier. The audible output device can be configured to output anaudible output in response to the electronic signal.

In some embodiments, an apparatus includes a simulated medicamentdelivery device and an electronic circuit system coupled to thesimulated medicament delivery device. The simulated medicament deliverydevice can be configured, for example, to simulate the look, feel and/orfunctionality associated with a pen injector, an auto-injector, aninhaler and/or a transdermal delivery device. The electronic circuitsystem is configured to output an electronic output associated with ause of the simulated medicament delivery device. The electronic outputcan include, for example, a signal associated with a visual output, anaudible output, a haptic output, an olfactory output and/or a tasteoutput. Moreover, the electronic output can include, for example, aninstruction for using the simulated medicament delivery device and/or amedicament delivery device

As used in this specification including the appended claims, the words“proximal” and “distal” refer to direction closer to and away from,respectively, an operator (e.g., surgeon, physician, nurse, technician,etc.) of the medical device. Thus, for example, the end of themedicament delivery device contacting the patient's body would be thedistal end of the medicament delivery device, while the end opposite thedistal end would be the proximal end of the medicament delivery device.

FIG. 1 is a schematic illustration of a medicament delivery device 1000having an acoustic enclosure, according to an embodiment of theinvention. The medicament delivery device 1000 includes a housing 1110,a medicament container 1560, a medicament delivery member 1512, and anelectronic circuit system 1900. The medicament container 1560, which canbe, for example, a pre-filled cartridge, a vial, an ampule, or the like,is disposed within the housing 1110. At least a portion of themedicament delivery member 1512 is disposed within the housing 1110. Insome configurations, the medicament delivery member 1512 can be in fluidcommunication with the medicament container 1560. In this manner, amedicament can be conveyed from the medicament container 1560 to aregion outside the housing 1110 via the medicament delivery member 1512.The medicament delivery member 1512 can include, for example, a needle,a nozzle, a mouthpiece, or the like.

In some embodiments, the medicament delivery device 1000 can be anysuitable medical injector for injecting a medicament into a body of apatient. For example, the medicament delivery device 1000 can be asyringe, pen injector, auto-injector, or the like. In other embodiments,the medicament delivery device 1000 can be an inhaler. In yet anotherembodiment, the medicament delivery device 1000 can be a transdermaldelivery system. In some embodiments, the medicament delivery device1000 can be a chronic-care medicament delivery device. Said another way,the medicament delivery device 1000 can be a reusable device containingmultiple doses of medicament. For example, a medicament delivery device1000 having multiple doses of medicament can be used to manage insulindelivery or the delivery of other medicaments (e.g., to treat MultipleSclerosis, Anemia, Rheumatoid Arthritis, Osteoporosis or the like),which can, in some instances, require daily, weekly, and/or monthlydosages. In other embodiments, the medicament delivery device 1000 canbe a single-use device. Said another way, the medicament delivery device1000 can contain a single dose of medicament. In yet other embodiments,the medicament delivery device 1000 can be a simulated medicamentdelivery device or trainer similar to the simulated medicament deliverydevices or trainers described in U.S. Patent Publication Number2008/0059133, entitled “Medical Injector Simulation Device,” filed Feb.27, 2007, which is incorporated herein by reference in its entirety.

The electronic circuit system 1900 includes an audible output device1956 and a cover 1170 coupled to the housing 1110. The audible outputdevice 1956, which can be, for example, a microspeaker, is configured toproduce an audible output OP11. Said another way, the audible outputdevice 1956 is configured to produce a set of sound waves in response toan electronic signal from the electronic circuit system 1900. In someembodiments, the electronic circuit system 1900 and the audible outputdevice 1956 can produce the audible output OP11 in association with theuse of the medicament delivery device 1000.

The electronic circuit system 1900 can include any suitable electroniccomponents operatively coupled to produce and/or output the audibleoutput OP11 and/or to perform the functions described herein. In someembodiments, the electronic circuit system 1900 can be similar to theelectronic circuit systems described in U.S. Patent Publication Number2008/0033393, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Jan. 9, 2007, which is incorporated herein by referencein its entirety.

The housing 1110 and the cover 1170 of the electronic circuit system1900 collectively define a region 1153. Although the region 1153 isillustrated in FIG. 1 as a two-dimensional area, the region 1153 isassociated with an enclosed volume or space within the housing 1110.Similarly stated, the region 1153 can be a cavity, a chamber, or anenclosure defined by the housing 1110 and the cover 1170. In someembodiments, the region 1153 can be associated with a volume or spacewithin the housing 1110 having at least one opening (not shown inFIG. 1) to an area outside of the housing 1110.

At least a portion of the electronic circuit system 1900 is disposedwithin the region 1153 of the housing 1110. The electronic circuitsystem 1900 is coupled to the housing 1110 such that the audible outputdevice 1956 is disposed within the region 1153 defined by the housing1110 and the cover 1170. Moreover, the volume associated with the region1153 is larger than the volume of the audible output device 1956. Inthis manner, the region 1153 can function as an acoustic enclosure forthe audible output device 1956. As an acoustic enclosure, the region1153 can be used to minimize or attenuate noise and/or to enhance theaudible output OP11 of the audible output device 1956. In someembodiments, the region 1153 can reduce noise by isolating and/orabsorbing sound and/or vibration associated with the audible outputdevice 1956. In some embodiments, the region 1153 can enhance theaudible output OP11 of an audible output device 1956 by acousticallyamplifying the audible output at one or more acoustic resonantfrequencies defined by the physical characteristics of the region 1153(e.g., volume, shape, or the like). In some embodiments, for example,the region 1153 defines at least one resonant acoustic frequency withinthe acoustic frequency range of the audible output device 1956.

The audible output OP11 can be, for example, an audible representationof a recorded message or speech, a single tone or a sequence of tones,and/or the like. In some embodiments, the audible output OP11 can beassociated with a pre-recorded speech, instruction, or prompt for usingthe medicament delivery device 1000. In other embodiments, the audibleoutput OP11 can be associated with post-use instructions or prompts,such as, for example, a recorded message notifying the user that themedicament delivery event is complete, instructing the user onpost-medicament delivery disposal and safety procedures, instructing theuser to seek post-medicament delivery medical treatment, and/or thelike. In yet other embodiments, the audible output OP11 can beassociated with the patient's compliance in using the medicamentdelivery device 1000. In some embodiments, the audible output OP11 canbe associated with an actuation of the medicament delivery device 1000.Said another way, the audible output device 1956 can be configured tooutput the audible output OP11 in response to the triggering oractivating of a function, procedure, and/or mode associated with themedicament delivery device 1000.

In yet other embodiments, the electronic circuit system 1900 can producean electronic output associated with the patient's compliance in usingmedicament the delivery device 1000. In some embodiments, such anelectronic output can be associated with an actuation of the medicamentdelivery device 1000. Said another way, the electronic circuit system1900 can be configured to output an electronic output in response toactuation of the medicament delivery device 1000. Such electronicoutputs can be, for example, a visual output such as, for example, atext message to display on a screen (not shown), and/or an LED. In someembodiments, an electronic output can be an audio output as describedherein, such as, for example, recorded speech, a series of tones, and/orthe like. In other embodiments, an electronic output can be a wirelesssignal configured to be received by a remote device. For example, insome embodiments, the electronic output can be a signal sent to acompliance tracking monitor to record the data and/or time of use of themedicament delivery device 1000.

Although the region 1153 is shown as being fully enclosed, in otherembodiments the region 1153 can be partially enclosed. In someembodiments, for example, the cover 1170 and/or the housing 1110 definean opening (not shown) through which the audible output device 1956 canbe disposed within the region 1153. In some embodiments, the shape ofthe audible output device 1956 can substantially match the shape of thepartially enclosed region 1153. In other embodiments, the volume of theaudible output device 1956 disposed within the partially enclosed region1153 is smaller than the volume of the partially enclosed region 1153.

FIG. 2 is a schematic illustration of a medicament delivery device 2000having a ported acoustic enclosure, according to an embodiment of theinvention. The medicament delivery device 2000 includes a housing 2110,a medicament container 2560, and an electronic circuit system 2900. Themedicament container 2560, which can be, for example, a pre-filledcartridge, a vial, an ampule, or the like, is disposed within thehousing 2110.

The medicament delivery device 2000 can be a reusable device containingmultiple doses of medicament. For example, a medicament delivery device2000 having multiple doses of medicament can be used to manage insulindelivery or the delivery of other medicaments (e.g., to treat MultipleSclerosis, Anemia, Rheumatoid Arthritis, Osteoporosis or the like),which can, in some instances, require daily, weekly, and/or monthlydosage. In other embodiments, the medicament delivery device 2000 can bea single-use device. Said another way, the medicament delivery device2000 can contain a single dose of medicament. In yet other embodiments,the medicament delivery device 2000 can be a simulated medicamentdelivery device or trainer.

The electronic circuit system 2900 can include any suitable electroniccomponents operatively coupled to produce and/or output the audibleoutput and/or to perform the functions described herein. The electroniccircuit system 2900 includes an audible output device 2956 and a cover2170 coupled to the housing 2110. The audible output device 2956, whichcan be, for example, a microspeaker, includes a front portion 2004 and aback portion 2003. The front portion 2004 of the audible output device2956 is configured to output a first audible output OP21 that includes afirst set of sound waves. The back portion 2003 of the audible outputdevice 2956 is configured to output a second audible output OP22 thatincludes a second set of sound waves. The first set sound wavesassociated with the first audible output OP21 can result from changes inair pressure that occur at the front portion 2004 of the audible outputdevice 2956 from, for example, a controlled movement of a portion of theaudible output device 2956 (e.g., a cone, membrane, diaphragm, or thelike). The second set of sound waves associated with the second audibleoutput OP22 can result from changes in air pressure that occur at theback portion 2003 of the audible output device 2956 from, for example,the movement of a portion of the audible output device 2956. In someembodiments, a single moving portion (e.g., a speaker cone) can produceboth the first set of sound waves and the second set of sound waves. Forexample, a movement of the cone that produces an increase in airpressure at the front portion 2004 of the audible output device 2956results in a corresponding decrease in air pressure at the back portion2003 of the audible output device 2956. Similarly, a movement of thecone that produces a decrease in air pressure at the front portion 2004of the audible output device 2956 results in a corresponding increase inair pressure at the back portion 2003 of the audible output device 2956.Accordingly, in some embodiments, the first set of sound waves producedat the front portion 2004 of the audible output device 2956 can beout-of-phase with the second set of sound waves produced at the backportion 2003 of the audible output device 2956. In this manner, theelectronic circuit system 2900 and the audible output device 2956 canproduce an audible output associated with the use of the medicamentdelivery device 2000.

The housing 2110 and the cover 2170 of the electronic circuit system2900 collectively define a region 2153. Although the region 2153 isillustrated in FIG. 2 as a two-dimensional area, the region 2153 isassociated with an enclosed volume or space within the housing 2110.Similarly stated, the region 2153 can be a cavity, a chamber, or anenclosure defined by the housing 2110 and the cover 2170. At least aportion of the electronic circuit system 2900 and/or the audible outputdevice 2956 is disposed within the region 2153 of the housing 2110. Inthis manner, the region 2153 can function as an acoustic enclosure forthe audible output device 2956.

The cover 2170 defines an opening 2001 through which the first set ofsound waves associated with the audible output OP21 can travel.Similarly, the housing 2110 defines an opening 2002 through which thesecond set of sound waves associated with the audible output OP22 cantravel. The opening 2002 can be referred to, for example, as a “port” ofthe acoustic enclosure associated with the region 2153. In someembodiments, the opening 2001 and the opening 2002 can be collectivelyconfigured such that the first set of sound waves associated with theaudible output OP21 when exiting the housing 2110 through the opening2001 is substantially in phase with the second set of sound wavesassociated with the audible output OP22 when exiting the housing 2110through the opening 2002. Similarly stated, in some embodiments, theopening 2002 can be positioned and/or oriented relative to the opening2001 to compensate, reduce and/or eliminate the phase difference thatcan exist between the first set of sound waves of the audible outputOP21 and the second set of sound waves of the audible output OP22 withinthe housing 2110. Said another way, in some embodiments, the distancethat the first set of sound waves of the audible output OP21 travels toexit through the opening 2001 (e.g., the distance between the frontportion 2004 of the audible output device 2956 and the exit of theopening 2001) and the distance that the second set of sound waves of theaudible output OP22 travels to exit through the opening 2002 (e.g., thedistance between the back portion 2003 of the audible output device 2956and the exit of the opening 2002) is such that the first set of soundwaves associated with the audible output OP21 when exiting the housing2110 is substantially in phase with the second set of sound wavesassociated with the audible output OP22 when exiting the housing 2110through the opening 2002. In this manner, the phase compensation thatresults from the difference between the exit path of the first set ofsound waves of the audible output OP21 and the exit path of the secondset of sound waves of the audible output OP22 can increase (e.g.,constructively interfere) the overall sound level of the audible outputdevice 2956 outside the housing 2110.

Although the cover 2170 is shown as defining the opening 2001, in otherembodiments, the housing 2110 can define both the opening 2001 and theopening 2002. Although the cover 2170 is described as defining a singleopening 2001, in other embodiments, the cover 2170 can define multipleopenings. Similarly, in some embodiments, the housing 2110 can definemultiple “ports” or openings. In some embodiments, the opening 2002 isconfigured to be selectively covered by a moveable member (not shown) ofthe medicament delivery device 2000. For example, the opening 2002 canbe selectively covered by at least one of a sleeve, a safety lock, or aneedle guard.

The audible outputs OP21 and OP22 can be related to instructions,notifications, messages, actuations, and/or compliance associated withusing the medicament delivery device 2000. The audible output OP21 andthe audible output OP22 can be, for example, a recorded message orspeech, a single tone or a sequence of tones, and/or the like. In thismanner, the electronic circuit system 2900 can output information to theuser through the audile outputs OP21 and OP22 in an unobtrusive mannerand/or without impeding the delivery of the medicaments. The audibleoutputs OP21 and OP22 can be, for example, audible representations of arecorded message or speech, single tones or sequences of tones, and/orthe like. In some embodiments, the audible outputs OP21 and OP22 can beassociated with a pre-recorded speech, instruction, or prompt for usingthe medicament delivery device 2000. In other embodiments, the audibleoutputs OP21 and OP22 can be associated with post-use instructions orprompts, such as, for example, a recorded message notifying the userthat the medicament delivery is complete, instructing the user onpost-medicament delivery disposal and safety procedures, instructing theuser to seek post-medicament delivery medical treatment, and/or thelike. In yet other embodiments, the audible outputs OP21 and OP22 can beassociated with the patient's compliance in using the medicamentdelivery device 2000. In some embodiments, the audible outputs OP21 andOP22 can be associated with an actuation of the medicament deliverydevice 2000. Said another way, the audible output device 2956 can beconfigured to output the audible outputs OP21 and OP22 in response tothe triggering or activating of a function, procedure, and/or modeassociated with the medicament delivery device 2000.

FIG. 3 is a schematic illustration of a medicament delivery device 3000according to an embodiment of the invention. The medicament deliverydevice 3000 includes a housing 3110, a medicament container 3560, amedicament delivery member 3512, and an electronic circuit system 3900.The medicament container 3560 is disposed within the housing 3110. Atleast a portion of the medicament delivery member 3512 is disposedwithin the housing 3110. The medicament container 3560 and/or themedicament delivery member 3512 can be substantially similar to themedicament container 1560 and/or the medicament delivery member 1512,respectively, as shown and described above with reference to FIG. 1.

The electronic circuit system 3900, which can be can be similar to theelectronic circuit system 1900 shown and described above with referenceto FIG. 1, includes an audio processor 3010 and an audible output device3956. The audio processor 3010 is configured to output an electronicoutput S31 to the audible output device 3956. The audio processor 3010can be software-based (e.g., set of instructions executable at aprocessor, software code) and/or hardware-based (e.g., circuit system,processor, application-specific integrated circuit (ASIC), fieldprogrammable gate array (FPGA)). The electronic output S31 can beassociated with, for example, a recorded message or speech, a singletone or a sequence of tones, and/or the like. In some embodiments, theelectronic circuit system 3900 and/or the audio processor 3010 caninclude a separate memory (not shown) in which information associatedwith a recorded message or speech, tones, or the like can be stored. Inthis manner, the audio processor 3010 can receive the recorded messageor tone information from the memory for processing and to produce theelectronic output S31. In some embodiments, for example, the audioprocessor 3010 can include an embedded or built-in memory module inwhich information associated with the recorded message or tone isstored.

As shown in FIG. 3, the electronic output S31 is conveyed from the audioprocessor 3010 to the audible output device 3956 via an electronic path3001 devoid of an amplifier. Similarly stated, no amplifiers and/ordrivers external to the audio processor 3010 are used to boost orincrease the electronic output S31. The electronic path 3001 can bedefined by any suitable electronic components. For example, in someembodiments, the electronic circuit system 3900 can have the audioprocessor 3010, the audible output device 3956, and/or the electronicpath 3001 disposed on one or more printed circuit boards (PCBs), Such anarrangement can reduce the cost and/or complexity of the electroniccircuit system 3900. Moreover, by excluding external amplifiers and/ordrivers, the power required to produce the audible output OP31 can berelatively low, as discussed in more detail herein.

The audible output device 3956, which can be, for example, amicrospeaker, is configured to produce the audible output OP31 inresponse to the electronic output S31. In this manner, the electroniccircuit system 3900 and the audible output device 3956 can produce anaudible output associated with the use of the medicament delivery device3000, as discussed above.

FIGS. 4A-29 show a medicament delivery device 4000, according to anembodiment of the invention. FIGS. 4A-4B are perspective views of themedicament delivery device 4000 in a first configuration (i.e., prior touse). The medicament delivery device 4000 is similar to the medicalinjectors described in U.S. patent application Ser. No. 12/119,016,entitled “Medicament Delivery Device Having an Electronic CircuitSystem,” filed May 12, 2008, which is incorporated herein by referencein its entirety. The medicament delivery device 4000 includes a housing4110, a medicament delivery mechanism 4500 (see e.g., FIG. 12), anelectronic circuit system 4900 (see e.g., FIGS. 13-21), a cover 4200(see e.g., FIGS. 22-23), a safety lock 4700 (see e.g., FIGS. 24-25) anda base 4300 (see e.g., FIG. 26). A discussion of the components of themedicament delivery device 4000 will be followed by a discussion of theoperation of the medicament delivery device 4000. In the embodimentsdescribed with respect to FIGS. 4A-29, the medicament delivery device4000 is a medical injector.

As shown in FIGS. 5-11, the housing 4110 has a proximal end portion 4140and a distal end portion 4120. The housing 4110 defines a first statusindicator aperture 4150 and a second status indicator aperture 4151. Thestatus indicator apertures 4150, 4151 can allow a patient to monitor thestatus and/or contents of a medicament container 4560. For example, byvisually inspecting the status indicator apertures 4150, 4151, a patientcan determine whether the medicament container 4560 contains amedicament and/or whether a medicament has been dispensed.

As shown in FIGS. 9 and 10, the housing 4110 defines a gas cavity 4154,a medicament cavity 4157, and an electronic circuit system cavity 4153.The gas cavity 4154 has a proximal end portion 4155 and a distal endportion 4156. The gas cavity 4154 is configured to receive the gascontainer 4570 and the release member 4540 of the medicament deliverymechanism 4500 (see e.g., FIG. 12), as described in further detailherein. The proximal end portion 4155 of the gas cavity 4154 isconfigured to receive the gas container retention member 4580 of theproximal cap 4112 of the housing 4110, as described in further detailherein. The gas cavity 4154 is in fluid communication with themedicament cavity 4157 via a gas passageway 4144 (see e.g., FIG. 11), asdescribed in further detail herein, and the gas cavity 4154 is in fluidcommunication with a region outside the housing 4110 via a safety lockaperture 4128.

The medicament cavity 4157 is configured to receive a portion of themedicament delivery mechanism 4500. In particular, the carrier 4520, themoveable member 4530 and the needle 4512 of the medicament deliverymechanism 4500 are movably disposed in the medicament cavity 4157. Themedicament cavity 4157 is in fluid communication with a region outsidethe housing 4110 via a needle aperture 4122.

The electronic circuit system cavity 4153 is configured to receive theelectronic circuit system 4900. The electronic circuit system cavity4153 is isolated from the gas cavity 4154 and/or the medicament cavity4157 via a side wall 4148 (see e.g., FIG. 10). Said another way, theelectronic circuit system cavity 4153 is acoustically separated fromand/or fluidically isolated from the gas cavity 4154 and/or themedicament cavity 4157. As described in more detail herein, theelectronic circuit system cavity 4153 can function as an acousticenclosure to enhance the magnitude and/or quality of the audible outputproduced by the electronic circuit system 4900.

The housing 4110 has protrusions 4149 (see e.g., FIG. 8) configured tostabilize the electronic circuit system 4900 when the electronic circuitsystem 4900 is disposed within the electronic circuit system cavity4153. The housing 4110 also defines connection apertures 4152 configuredto receive connection protrusions 4171A and 4171B (see e.g., FIG. 13) ofthe electronic circuit system 4900, and aperture 4145 (see e.g., FIG. 6)configured to receive a portion of a protrusion 4174 of the electroniccircuit system 4900. In this manner, the electronic circuit system 4900can be coupled to the housing 4110 within the electronic circuit systemcavity 4153. In other embodiments, the electronic circuit system 4900can be coupled within the electronic circuit system cavity 4153 by othersuitable means such as an adhesive, a clip and/or the like.

The proximal end portion 4140 of the housing 4110 includes a proximalcap 4112, a speaker protrusion 4147 (see e.g. FIGS. 8 and 9), and coverretention protrusions 4142 (see e.g., FIGS. 4B and 6). The speakerprotrusion 4147 is configured to maintain a position of an audibleoutput device 4956 relative to the housing 4110 and/or an electroniccircuit system cover 4170 when the electronic circuit system 4900 isattached to the housing 4110. As described in more detail below, in someembodiments, the speaker protrusion 4147 can press the front portion4957 of the audible output device 4956 against the electronic circuitsystem cover 4170 to form a substantially airtight (e.g., asubstantially hermetic) seal between the front portion 4957 of theaudible output device 4956 and the electronic circuit system cover 4170.A substantially airtight seal can reduce undesirable audible noise thatcan result from air leaking through a gap between the front portion 4957of the audible output device 4956 and the electronic circuit systemcover 4170. Moreover, the speaker protrusion 4147 can reduce or minimizeundesirable vibration of the audible output device 4956 by holding theaudible output device 4956 in a substantially fixed position relative tothe electronic circuit system cover 4170. The cover retentionprotrusions 4142 are configured to be received within correspondingopenings 4215 on the cover 4200. In this manner, as described in moredetail herein, the cover 4200 can be removably coupled to and disposedabout at least a portion of the housing 4110.

As shown in FIG. 11, the proximal cap 4112 includes a gas containerretention member 4580 and defines a gas passageway 4144. The gascontainer retention member 4580 is configured to receive and/or retain agas container 4570 that can contain a pressurized gas. The gaspassageway 4144 is configured to allow for the passage of gas containedin the gas container 4570 from the gas cavity 4154 to the medicamentcavity 4157, as further described herein. Said another way, the gaspassageway 4144 places the gas cavity 4154 in fluid communication withthe medicament cavity 4157.

As shown in FIGS. 7 and 9, the distal end portion 4120 of the housing4110 defines a battery isolation protrusion aperture 4121, a needleaperture 4122, a safety lock actuator groove 4123, a safety lockaperture 4128, a base actuator groove 4124, base retention recesses4125A, 4125B, and base rail grooves 4127. The base 4300 is moveablycoupled to the distal end portion 4120 of the housing 4110. The batteryisolation protrusion aperture 4121 is configured to receive the batteryisolation protrusion 4235 of the cover 4200 (see e.g., FIG. 23) when thecover 4200 is disposed about the housing 4110, as described in furtherdetail herein. When the cover 4200 is moved relative to the housing 4100to enable the medicament delivery device 4000 (see e.g., FIG. 27), thebattery isolation protrusion aperture 4121 places the electronic circuitsystem cavity 4153 in fluid communication with a region outside of thehousing 4110. Said another way, when the cover 4200 is moved relative tothe housing 4100, the battery isolation protrusion aperture 4121 definesan opening through which sound waves produced by a back portion 4955 ofthe audible output device 4956 can exit the housing 4110.

The needle aperture 4122 is configured to allow the needle 4512 (seee.g., FIG. 12) to exit the housing 4110 when the medical injector 4000is actuated. The portion of the sidewall of the housing 4110 thatdefines the needle aperture 4122 includes multiple sheath retentionprotrusions 4126. In some embodiments, the sheath retention protrusionscan interact with the plurality of ribs 4728 of the needle sheath 4720(see e.g. FIGS. 24A and 24B) to maintain a position of the needle sheath4720 relative to the safety lock 4700 when the safety lock 4700 iscoupled to the housing 4110 and/or when the safety lock 4700 is beingremoved from the housing 4110.

The safety lock actuator groove 4123 is configured to receive anactuator 4744 of the safety lock 4700. As described in more detailherein, the actuator 4744 is configured to engage and/or activate theelectronic circuit system 4900 when the safety lock 4700 is moved withrespect to the housing 4110. The safety lock aperture 4128 is configuredto receive a safety lock protrusion 4742 (see e.g., FIGS. 25 and 26). Asdescribed in more detail below, the safety lock protrusion 4742 isreceived within an opening 4554 between extensions 4552 of a releasemember 4540 such that activation of the medical injector 4000 isprevented when the safety lock 4700 is in place. The safety lock 4700,its components and functions are further described herein.

The distal base retention recesses 4125A are configured to receive thebase connection knobs 4358 of the base (see e.g., FIG. 26) when the baseis in a first position relative to the housing 4110. The proximal baseretention recesses 4125B are configured to receive the base connectionknobs 4358 of the base when the base is in a second position relative tothe housing 4110. The base retention recesses 4125A, 4125B have atapered proximal sidewall and a non-tapered distal sidewall. This allowsthe base retention recesses 4125A, 4125B to receive the base connectionknobs 4358 such that the base can move proximally relative to thehousing 4110, but cannot move distally relative to the housing 4110.Said another way, the distal base retention recesses 4125A areconfigured to prevent the base from moving distally when the base is ina first position and the proximal base retention recesses 4125B areconfigured to prevent the base from moving distally when the base is ina second position. Similarly stated, the proximal base retentionrecesses 4125B and the base connection knobs 4358 cooperatively prevent“kickback” after the medical injector 4000 is actuated.

The base actuator groove 4124 is configured to receive an actuator 4311of the base. As described in more detail herein, the actuator 4311 ofthe base is configured to engage the electronic circuit system 4900 whenthe base 4100 is moved with respect to the housing 4110. The base railgrooves 4127 are configured to receive the guide members 4312 of thebase. The guide members 4312 of the base and the base rail grooves 4127of the housing 4110 engage each other in a way that allows the guidemembers 4312 of the base to slide in a proximal and/or distal directionwithin the base rail grooves 4127 while limiting lateral movement of theguide members 4312. This arrangement allows the base to move in aproximal and/or distal direction with respect to the housing 4110 butprevents the base from moving in a lateral direction with respect to thehousing 4110.

FIG. 12 shows the medicament delivery mechanism 4500 of the medicamentdelivery device 4000. The medicament delivery device 4000 is similar tothe auto-injectors described in U.S. Patent Application PublicationNumber 2007/0149925, entitled “Devices, Systems and Methods forMedicament Delivery,” filed Nov. 21, 2006, which is incorporated hereinby reference in its entirety. Accordingly, only an overview of themedicament delivery mechanism 4500 and related operation of themedicament delivery device 4000 is included below.

The medicament delivery mechanism 4500 includes a needle 4512, a carrier4520, a movable member 4530, a medicament container 4560, a gascontainer 4570, and a release member 4540. As described above, theneedle 4512, carrier 4520, movable member 4530 and medicament container4560 are disposed within the medicament cavity 4157 of the housing 4110.The gas container 4570 and the release member 4540 are disposed withinthe gas cavity 4154 of the housing 4110.

The release member 4540 is movably disposed within the distal endportion 4156 of the gas cavity 4154. A proximal end portion 4542 of therelease member 4540 includes a sealing member 4545 and a puncturer 4541.The sealing member 4545 is configured to engage the sidewall of thehousing 4110 defining the gas cavity 4154 such that the proximal endportion 4155 of the gas cavity 4154 is fluidically isolated from thedistal end portion 4156 of the gas cavity 4154. In this manner, when gasis released from the gas container 4570, the gas contained in theproximal end portion 4155 of the gas cavity 4154 is unable to enter thedistal end portion 4156 of the gas cavity 4154. The puncturer 4541 isconfigured to contact and puncture a frangible seal 4573 on the gascontainer 4570 when the release member 4540 moves proximally within thegas cavity 4154, as shown by the arrow BB in FIG. 12.

A distal end portion 4544 of the release member 4540 includes extensions4552. The extensions 4552 include projections 4547 that include taperedsurfaces 4549 and engagement surfaces 4548. Further, the extensions 4552define an opening 4554 between the extensions 4552. The engagementsurfaces 4548 of the projections 4547 are configured to extend throughthe safety lock aperture 4128 of the housing 4110 and contact a distalsurface of the housing 4110. In this manner, the engagement surfaces4548 of the projections 4547 limit proximal movement of the releasemember 4540 when the engagement surfaces 4548 are in contact with thedistal surface of the housing 4110. The tapered surfaces 4549 of theprojections 4547 are configured to contact protrusions 4313 on aproximal surface 4310 of the base 4300 (see e.g., FIG. 26). In thismanner, proximal movement of the base 4300 causes the extensions 4552 tomove together, thereby releasing the engagement surfaces 4548 from thehousing 4110 and allowing the release member 4540 to move proximallywithin the gas cavity 4154.

The opening 4554 defined by the extensions 4552 is configured to receivethe safety lock protrusion 4742 of the safety lock 4700 (see e.g., FIG.24). The safety lock protrusion 4742 is configured to ensure that theextensions 4552 remain apart and the engagement surfaces 4548 of theprojections 4547 remain in contact with the distal end portion 4120 ofthe housing 4110. In some embodiments, for example, the release member4540 and/or the extensions 4552 can be constructed from any suitablematerial configured to withstand deformation that may occur when exposedto a load over an extended period of time.

The gas container 4570 is configured to contain a pressurized gas, andhas a frangible seal 4573 at the distal end thereof. The frangible seal4573 is configured to break when the puncturer 4541 of the proximal endportion 4542 of the release member 4540 contacts the frangible seal4573. The gas container retention member 4580 of the proximal cap 4112of the housing 4110 is configured to receive and/or retain the proximalend portion 4576 of the gas container 4570 to maintain the position ofthe gas container 4570. The medicament container 4560 of the medicamentdelivery mechanism 4500 is configured to contain a medicament. A distalend portion 4562 of the medicament container 4560 contains a seal 4523configured to burst when punctured by a proximal end 4516 of the needle4512, as described below. A proximal end portion 4566 of the medicamentcontainer 4560 is configured to receive a piston portion 4534 of themovable member 4530.

The movable member 4530 of the medicament delivery mechanism 4500 ismovably disposed within the medicament cavity 4157. The movable member4530 includes the piston portion 4534 having a plunger (not shown) atthe distal end portion of the piston portion 4534. The piston portion4534 is configured to move within the medicament container 4560. In thismanner, the piston portion 4534 of the movable member 4530 can apply orexert pressure to a medicament contained in the medicament container4560. The piston portion 4534 can be constructed of a resilient,durable, and/or sealing material, such as a rubber, for example.

The carrier 4520 of the medicament delivery mechanism 4500 includes adistal end portion 4522 and a proximal end portion 4526. The medicamentcontainer 4560 is coupled to the carrier 4520 via a “snap-fit”connection (not shown) such that the medicament container 4560 can moverelative to the carrier 4520 between a first configuration and a secondconfiguration during an injection event. In the first configuration, thecarrier 4520 is configured to move within the medicament cavity 4157such that movement of the carrier 4520 within the medicament cavity 4157causes contemporaneous movement of the medicament container 4560 withinthe medicament cavity 4157. The proximal end portion 4516 of the needle4512 is spaced apart from the seal 4523 of the medicament container 4560when the carrier 4520 is in the first configuration. In the secondconfiguration, the medicament container 4560 releases from the“snap-fit” causing the medicament container 4560 to move distally withrespect to the carrier 4520, causing the proximal end portion 4516 ofthe needle 4512 to pierce the seal 4523. In this manner, the needle 4512can be selectively placed in fluid communication with the medicamentcontainer 4560 to define a medicament delivery path (not shown).

FIGS. 13-20 show the electronic circuit system 4900. The electroniccircuit system is configured to produce and/or output an audible outputassociated with a use of the medicament delivery device 4000. Theelectronic circuit system 4900 of the medicament delivery device 4000includes the electronic circuit system cover 4170 shown and describedabove with reference to FIG. 7, a printed circuit board 4922, aprocessor 4950, a battery assembly 4962, an audible output device 4956,two light emitting diodes (LEDs) 4958A and 4958B, and a battery clip4910. As shown in FIG. 22, the electronic circuit system 4900 isconfigured to fit within the electronic circuit system cavity 4153 ofthe housing 4110. Accordingly, as described above, the electroniccircuit system 4900 is physically, acoustically, and/or fluidicallyisolated from the medicament cavity 4157 and/or the gas cavity 4154.

The electronic components (e.g., the printed circuit board 4922, thebattery assembly 4962, and the like) are mounted to the electroniccircuit system cover 4170. The electronic circuit system cover 4170includes a distal end portion 4180 and a proximal end portion 4190. Theproximal end portion 4190 includes connection protrusions 4171A and abattery clip protrusion 4173. The connection protrusions 4171A extendfrom the proximal end portion 4190 of the electronic circuit systemcover 4170, and are configured to be disposed within the connectionapertures 4152 of the housing 4110, as described above. In this manner,the electronic circuit system 4900 can be coupled to the housing 4110within the electronic circuit system cavity 4153. In other embodiments,the electronic circuit system 4900 can be coupled to the housing 4110 byother suitable means such as an adhesive, a clip and/or the like.

The proximal end portion 4190 of the electronic circuit system cover4170 defines multiple sound apertures 4191. The audible output device4956 is disposed against the proximal end portion 4190 of the electroniccircuit system cover 4170 such that the front portion 4957 of theaudible output device 4956 is disposed adjacent the sound apertures4191. In this manner, sound waves from the audible output device 4956can travel from the audible output device 4956 to a region outside ofthe housing 4110 via the sound apertures 4191. As described above, insome embodiments, a sealing material (e.g., a compressible adhesivefoam, an elastomeric o-ring, or the like) can be disposed on an outerperimeter of the front portion 4957 of the audible output device 4956such that when the audible output device 4956 is pressed against theelectronic circuit system cover 4170 by the speaker protrusion 4147, asubstantially airtight seal is formed between the front portion 4957 ofthe audible output device 4956 and the electronic circuit system cover4170. In this manner, sound waves produced by the front portion 4957 ofthe audible output device 4956 are directed through the multiple soundapertures 4191 and not through a breach or gap between the audibleoutput device 4956 and the electronic circuit system cover 4170. In someembodiments, for example, the sealing material is a compressibleadhesive foam approximately ¾millimeters in thickness that coversapproximately 10 percent of the front portion 4957 of the audible outputdevice 4956.

As shown in FIGS. 18 and 19, the distal end portion 4180 of theelectronic circuit system cover 4170 includes a connection protrusion4171B, a stiffening protrusion 4174, and defines an LED aperture 4181and an aperture 4172. The LED aperture 4181 is configured to receive theLEDs 4958A, 4958B such that a user can view the LEDs 4958A, 4958B, whichare described in more detail herein. The connection protrusion 4171Bextends from the distal end portion 4180 of the electronic circuitsystem cover 4170, and is configured to attach the electronic circuitsystem 4900 to the housing 4110, as described above. The stiffeningprotrusion 4174 is configured to have at least a portion received withinand/or accessible via the aperture 4145 in the housing 4110 (see e.g.,FIG. 6). The stiffening protrusion 4174 is configured to limit thebending (e.g., buckling) of the electronic circuit system cover 4170when the electronic circuit system cover 4170 is coupled to the housing4110.

The electronic circuit system cover 4170 is matingly coupled to thehousing 4110 such that the electronic circuit system cover 4170 and theelectronic circuit system cavity 4153 collectively define an acousticenclosure within which the audible output device 4956 is disposed. Saidanother way, the electronic circuit system cover 4170 and the electroniccircuit system cavity 4153 collectively form a region, volume and/orspace that is configured to minimize or attenuate noise and/or enhancethe audible output of the audible output device 4956. Moreover, thevolume associated with the region defined by the electronic circuitsystem cover 4170 and the electronic circuit system cavity 4153 islarger than the volume of the audible output device 4956 and/or theelectronic circuit system 4900 disposed within the region. In thismanner, the acoustic enclosure defined by the electronic circuit systemcover 4170 and the electronic circuit system cavity 4153 is configuredto contain a volume of air behind the audible output device 4956.

The safety lock actuator groove 4182 of the electronic circuit systemhousing 4170 is configured to be disposed adjacent the safety lockactuator groove 4123 of the distal end portion 4120 of the housing 4110.In this manner, the safety lock actuator groove 4182 of the electroniccircuit system housing 4170 and the safety lock actuator groove 4123 ofthe distal end portion 4120 of the housing 4110 collectively receive theactuator 4744 of the safety lock 4700, which is described in more detailherein. Similarly, the base actuator groove 4183 of the electroniccircuit system housing 4170 is configured to be disposed about the baseactuator groove 4124 of the distal end portion 4120 of the housing 4110.The base actuator groove 4183 of the electronic circuit system housing4170 and the base actuator groove 4124 of the distal end portion 4120 ofthe housing 4110 collectively receive the actuator 4311 of the base,which is described in more detail herein.

Moreover, the audible output device 4956 and the electronic circuitsystem cavity 4153 are collectively configured to enhance the qualityand/or magnitude of the sound produced by the audible output device4956. For example, in some embodiments, the size and/or shape of theelectronic circuit system cavity 4153 can be configured such that theelectronic circuit system cavity 4153 defines an acoustic resonantfrequency that is within a predefined frequency range of the audibleoutput device 4956. More particularly, in some embodiments, theelectronic circuit system cavity 4153 can be configured such that theelectronic circuit system cavity 4153 defines an acoustic resonantfrequency that is substantially the same as a resonant frequency of theaudible output device 4956. In this manner, the quality and/or magnitudeof the sound produced by the audible output device 4956 can be enhancedfor a particular range of frequencies. In some embodiments, the qualityand/or magnitude of the sound produced by the audible output device 4956can be enhanced for a frequency range corresponding to the frequencyrange of a recorded speech output.

As shown in FIGS. 14 and 15, the printed circuit board 4922 of theelectronic circuit system 4900 includes a substrate 4924, a firstactuation portion 4926 and a second actuation portion 4946. The printedcircuit board 4922 provides the structure upon which at least a portionof the electronic components of the electronic circuit system 4900 aremounted. Moreover, the printed circuit board 4922 includes conductiveportions (e.g., copper traces, insulated wires, flexible wires or thelike) to electronically couple the components.

As shown in FIGS. 21A-21C, the first actuation portion 4926 includes afirst electrical conductor 4934 and defines an opening 4928 having aboundary 4929. The opening 4928 of the first actuation portion 4926 isconfigured to receive a protrusion 4746 of the actuator 4744 of thesafety lock 4700. The boundary 4929 of the first opening 4928 has adiscontinuous shape, such as, for example, a teardrop shape, thatincludes a stress concentration riser 4927. The discontinuity and/or thestress concentration riser 4927 of the boundary 4929 can be of anysuitable shape to cause the substrate 4924 to deform in a predetermineddirection when the protrusion 4746 of the actuator 4744 of the safetylock 4700 is moved relative to the opening 4928, as shown by the arrowCC in FIG. 21B.

The opening 4928 is defined adjacent the first electrical conductor 4934that electronically couples the components included in the electroniccircuit system 4900. The first electrical conductor 4934 includes afirst switch 4972, which can be, for example a frangible portion of thefirst electrical conductor 4934. In use, when the safety lock 4700 ismoved from a first position (see e.g., FIG. 21A) to a second position(see e.g., FIG. 21B), the actuator 4744 moves in a directionsubstantially parallel to a plane defined by a surface of the firstactuation portion 4926 of the substrate 4924. The movement of theactuator 4744 causes the protrusion 4746 to move within the firstopening 4928, as indicated by the arrow CC in FIG. 21B. The movement ofthe protrusion 4746 tears the first actuation portion 4926 of thesubstrate 4924, thereby separating the portion of the first electricalconductor 4934 including the first switch 4972. Said another way, whenthe safety lock 4700 is moved from its first position to its secondposition (see e.g., FIG. 29), the actuator 4744 moves irreversibly thefirst switch 4972 from a first state (e.g., a state of electricalcontinuity) to a second state (e.g., a state of electricaldiscontinuity). Said yet another way, when the safety lock 4700 is movedfrom its first position to its second position, the actuator 4744disrupts the first electrical conductor 4934.

The second actuation portion 4946 includes a second electrical conductor4935 and defines an opening 4945, having a boundary 4949 and a tearpropagation limit aperture 4948. As shown, the opening 4945 of thesecond actuation portion 4946 is configured to receive a portion of anactuator 4311 of the base. The boundary 4949 of the opening 4945 has adiscontinuous shape that includes a stress concentration riser 4947. Thediscontinuity and/or the stress concentration riser 4947 of the boundary4949 can be of any suitable shape to cause the substrate 4924 to deformin a predetermined direction when the actuator 4311 of the base is movedin a proximal direction relative to the opening 4945, as shown by thearrow DD in FIG. 21C.

The second electrical conductor 4935 includes a second switch 4973disposed between the opening 4945 and the tear propagation limitaperture 4948, which can be, for example, a frangible portion of thesecond electrical conductor 4935. In use, when the base is moved fromits first position to its second position (see e.g., FIG. 29), theactuator 4311 moves in a proximal direction, substantially parallel to aplane defined by a surface of the second actuation portion 4946 of thesubstrate 4924. The proximal movement of the actuator 4311 tears thesecond actuation portion 4946 of the substrate 4924, thereby separatingthe portion of the second electrical conductor 4935 including the secondswitch 4973. Said another way, when the base is moved from its firstposition to its second position, the actuator 4311 moves irreversiblythe second switch 4973 from a first state (e.g., a state of electricalcontinuity) to a second state (e.g., a state of electricaldiscontinuity). The tear propagation limit aperture 4948 is configuredto limit the propagation of the tear in the substrate 4924 in theproximal direction. Said another way, the tear propagation limitaperture 4948 is configured to ensure that the tear in the substrate4924 does not extend beyond the tear propagation limit aperture 4948.The tear propagation limit aperture 4948 can be any shape configured tostop the propagation of a tear and/or disruption of the substrate 4924.For example, the tear propagation limit aperture 4948 can be ovalshaped. In other embodiments, the proximal boundary of the tearpropagation limit aperture 4948 can be reinforced to ensure that thetear in the substrate 4924 does not extend beyond the tear propagationlimit aperture 4948.

The processor 4950 is configured to process electronic inputs (e.g.,from input switches) and produce electronic signals and/or outputs. Asdescribed herein, such electronic signals can include signals related toaudio or visual outputs associated with a use of the medicament deliverydevice 4000. More particularly, the processor 4950 is configured tooutput an electronic signal to the audible output device 4956, whichthen converts the electronic signal into sound waves. Said another way,the processor 4950 is configured to output an electronic signalassociated with an audible output to the audible output device 4956,which is configured to output the audible output. The electronic signalcan be associated with, for example, recorded speech, a single tone, asequence of tones, and/or the like. In this manner, the electroniccircuit system 4900 can produce and/or output an audible outputassociated with a use of the medicament delivery device 4000.

The electronic signals produced by the processor 4950 are conveyed tothe audible output device 4956 via one or more electronic paths (notidentified in FIG. 15) defined by the printed circuit board 4922 (e.g.,conductive traces or the like). As shown in FIG. 16, the electronicpaths between the processor 4950 and the audible output device 4956 aredevoid of an amplifier. Similarly stated, no amplifiers and/or driversexternal to the processor 4956 are used to amplify or increase theelectronic signals produced by the processor 4950. This arrangement canreduce the cost and/or complexity of the electronic circuit system 4900.Moreover, by being devoid of external amplification, the power of theelectronic signals conveyed to the audible output device 4956 can berelatively low. In this manner, the life of the battery assembly 4962can be extended, the battery assembly 4962 can include smaller batteriesand/or the battery assembly 4962 can include fewer batteries. In someembodiments, for example, the electronic signal produced by theprocessor 4950 can have a power of less than 500 milliwatts (mW). Inother embodiments, the electronic signal produced by the processor 4950can have a power of less than 100 milliwatts (mW). In yet otherembodiments, the electronic signal produced by the processor 4950 canhave a power of approximately 80 milliwatts (mW).

The processor 4950 can be a commercially-available processing devicededicated to performing one or more specific tasks. For example, in someembodiments, the processor 4950 can be a commercially-availablemicroprocessor, such as the Sonix SNC 12060 voice synthesizer.Alternatively, the processor 4950 can be an application-specificintegrated circuit (ASIC) or a combination of ASICs, which are designedto perform one or more specific functions. In yet other embodiments, theprocessor 4950 can be an analog or digital circuit, or a combination ofmultiple circuits. In some embodiments, the processor 4950 can beprogrammed through, for example, an internal controller (not shown) suchthat varied applications, including voice section combination, keytrigger arrangement, and/or output control, for example, can beimplemented.

The processor 4950 can include a memory device (not shown) configured toreceive and store information, such as a series of instructions,processor-readable code, a digitized signal, or the like. For example,the memory device can store operating code, recorded speech or voicecode, and/or data code. The memory device can include one or more typesof memory. For example, the memory device can include a read only memory(ROM) component and a random access memory (RAM) component. The memorydevice can also include other types of memory suitable for storing datain a form retrievable by the processor 4950, for example,electronically-programmable read only memory (EPROM), erasableelectronically-programmable read only memory (EEPROM), or flash memory.In some embodiments, a memory device separate from the processor 4950can be used to receive and store information.

The battery assembly 4962 of the electronic circuit system 4900 includestwo batteries stacked on top of one another. The batteries can be, forexample, three volt, “watch-style” lithium batteries. The batteryassembly 4962 has a first surface 4964 and a second surface 4966. Thefirst surface 4964 of the battery assembly 4962 can contact anelectrical contact (not shown) disposed on the substrate 4924. Thesecond surface 4966 of the battery assembly 4962 is configured tocontact a contact portion 4918 of a distal end portion 4916 of a batteryclip 4910. When both the electrical contact of the substrate 4924 andthe contact portion 4918 of the distal end portion 4916 of the batteryclip 4910 contact the battery assembly 4962, the batteries of thebattery assembly 4962 are placed in electrical communication with theelectronic circuit system 4900. Said another way, when the electricalcontact of the substrate 4924 and the contact portion 4918 of the distalend portion 4916 of the battery clip 4910 contact the battery assembly4962, the battery assembly 4962 is configured to supply power to theelectronic circuit system 4900.

The battery clip 4910 (shown in FIG. 20) includes a proximal end portion4912 and a distal end portion 4916. The proximal end portion 4912defines a retention aperture 4913. The retention aperture 4913 isconfigured to receive the battery clip protrusion 4173 of the electroniccircuit system cover 4170. In this manner, the battery clip protrusion4173 maintains the position of the battery clip 4910 with respect to theelectronic circuit system cover 4170 and/or the battery assembly 4962.

The distal end portion 4916 of the battery clip 4910 includes a contactportion 4918 and an angled portion 4917. As described above, the contactportion 4918 is configured to contact the second surface 4916 of thebattery assembly 4962 to place the battery assembly 4962 in electricalcommunication with the electronic circuit system 4900. The angledportion 4917 of the distal end portion 4916 of the battery clip 4910 isconfigured to allow a proximal end portion 4236 of a battery isolationprotrusion 4235 (see e.g., FIG. 23) to be disposed between the secondsurface 4966 of the battery assembly 4962 and the contact portion 4918of the distal end portion 4916 of the battery clip 4910. When thebattery isolation protrusion 4235 is disposed between the second surface4966 of the battery assembly 4962 and the contact portion 4918 of thedistal end portion 4916 of the battery clip 4910, the electrical pathbetween the battery assembly 4962 and the remainder of the electricalcircuit system 4900 is severed, thereby removing power from theelectronic circuit system 4900. The contact portion 4918 of the distalend portion 4916 of the battery clip 4910 is biased such that when thebattery isolation protrusion 4235 is removed, the contact portion 4918will move into contact the second surface 4916 of the battery assembly4962, thereby restoring electrical communication between the batteryassembly 4962 and the electronic circuit system 4900. In someembodiments, the battery isolation protrusion 4235 can be repeatedlyremoved from between the second surface 4966 of the battery assembly4962 and the contact portion 4918 of the distal end portion 4916 of thebattery clip 4910 and reinserted. Said another way, the batteryisolation protrusion 4235 and the battery clip 4910 collectively form areversible on/off switch.

When the battery isolation protrusion 4235 is disposed between thesecond surface 4966 of the battery assembly 4962 and the contact portion4918 of the distal end portion 4916 of the battery clip 4910, a portionof the battery isolation protrusion 4235 is also disposed within thebattery isolation protrusion aperture 4121. Conversely, when the batteryisolation protrusion 4235 is removed from between the second surface4966 of the battery assembly 4962 and the contact portion 4918 of thedistal end portion 4916 of the battery clip 4910 the battery isolationprotrusion aperture 4121 is opened. In this manner, the batteryisolation protrusion 4235 can selectively open and/or close the batteryisolation protrusion aperture 4121. In this regard, the batteryisolation protrusion aperture 4121 can selectively function as a port toallow sound waves produced by the audible output device 4956 to exit theelectronic circuit system cavity 4153 to an area outside the housing4110. As described herein, in some embodiments, the location of thebattery isolation protrusion aperture 4121 with respect to the locationof the audible output device 4956 and/or the sound apertures 4191 issuch that the sound waves that exit through the multiple sound apertures4191 are substantially in phase with the sound waves that exit throughthe battery isolation protrusion aperture 4121.

The audible output device 4956 of the electronic circuit system 4900 isconfigured to output audible sound associated with a use of themedicament delivery device 4000. The audible output device 4956 can haveany suitable performance characteristics to produce the desired audibleoutput (e.g., an audible output having a predefined frequency range, apredefined sound pressure level, etc.) based on the electronic signalsproduced by the processor 4950, as described above. For example, theaudible output device 4956 can have a specified resonance frequency, aspecified output sound pressure level (e.g., Watts/meter), a specifiedmaximum input power rating, and/or a specified frequency response range.The audible output device 4956 can have one or more resonant frequencieswithin the specified frequency response range. In some embodiments, theaudible output device 4956 can be a commercially-available micro-speakersuch as an M0015N07K01F micro-speaker manufactured by Dain(International) Co., Ltd. In other embodiments, the audible outputdevice 4956 can be an RS-1511A micro-speaker manufactured by RegalElectronics, Inc., for example.

As shown in FIGS. 13 and 14, the audible output device 4956 includes afront portion 4957 and a back portion 4955. The audible output device4956 can include a movable portion (e.g., a cone, membrane, diaphragm,or the like; not shown in FIGS. 13 and 14) such that the audible outputdevice 4956 can produce a first set of sound waves from the frontportion 4957 and a second set of sound waves from the back portion 4955.The sound waves produced by the front portion 4957 and the sound wavesproduced by the back portion 4955 collectively define the audible outputof the audible output device 4956. More particularly, the audible outputof the audible output device 4956 is characterized by the sound wavesproduced by the front portion 4957 and the sound waves produced by theback portion 4955 as they exit the electronic circuit system cavity 4153through the sound apertures 4191 and the battery isolation protrusionaperture 4121, respectively.

As described above, the audible output device 4956 and the electroniccircuit system cavity 4153 are collectively configured to enhance thequality and/or magnitude of the sound produced by the audible outputdevice 4956. Similarly stated, the size, shape and/or number andlocation of openings (e.g., the sound apertures 4191 and the batteryisolation protrusion aperture 4121) of the electronic circuit systemcavity 4153 are configured to enhance the quality of the audible outputproduced by the audible output device 4956 having predefined performancecharacteristics. In some embodiments, for example, the electroniccircuit system cavity 4153 and the electronic circuit system cover 4170are configured such that the sound waves produced by the front portion4957 as they exit through the sound apertures 4191 are substantially inphase with the sound waves produced by the back portion 4955 as theyexit through the battery isolation protrusion aperture 4121. This can beaccomplished, for example, by spacing the sound apertures 4191 apartfrom the battery isolation protrusion aperture 4121 by a predetermineddistance. In this manner, the distance through which the sound wavesproduced by the front portion 4957 travel to exit through the soundapertures 4191 and the distance through which the sound waves producedby the back portion 4955 travel to exit through the battery isolationprotrusion aperture 4121 can be set to predetermined values such thatthe sound waves produced by the front portion 4957 are substantially inphase with the sound waves produced by the back portion 4955 as theyexit the sound apertures 4191 and the battery isolation protrusionaperture 4121, respectively. For example, in some embodiments, the soundapertures 4191 can be spaced apart from the battery isolation protrusionaperture 4121 by approximately 2.5 inches to 3 inches. In otherembodiments, the sound apertures 4191 can be spaced apart from thebattery isolation protrusion aperture 4121 by approximately 1 inch to 3inches.

In some embodiments, the audible output device 4956 and the electroniccircuit system cavity 4153 can be collectively “tuned” to enhance thequality of an audible output having a specific frequency range. Forexample, in some embodiments, the audible output device 4956 and theelectronic circuit system cavity 4153 can be collectively “tuned” toenhance the quality of a recorded speech output. As described above, insome embodiments, the size and/or shape of the electronic circuit systemcavity 4153 can be configured such that the electronic circuit systemcavity 4153 defines an acoustic resonant frequency that is within afrequency range of the audible output device 4956 and/or a frequencyrange of a recorded speech output. In some embodiments, for example, theelectronic circuit system cavity 4153 can define at least one acousticresonant frequency of between about 100 hertz and about 1000 hertz. Inother embodiments, the electronic circuit system cavity 4153 can defineat least one acoustic resonant frequency of between about 100 hertz andabout 3000 hertz.

By enhancing the audible output produced by the audible output device4956 as described above, the medicament delivery device 4000 can produceaudible outputs associated with recorded speech having sufficient volume(e.g., sound pressure level) and without external amplification. In thismanner, the power required to produce such audible outputs can beminimized. For example, in some embodiments, the processor 4950 can beconfigured to output an electronic output to the audible output device4956 such that the audible output device 4956 outputs an audible outputhaving a sound pressure level in a range between about 61 decibels (dB)and about 65 dB. In another embodiment, the audible output can have asound pressure level in a range between about 61 decibels (dB) and about65 dB at a distance of about 6 inches from the audible output device4956. In yet other embodiments, the audible output can have a soundpressure level in a range between about 61 decibels (dB) and about 65 dBwithin a distance of about 20 feet from the audible output device 4956.

In other embodiments, the processor 4950 can be configured to output anelectronic output to the audible output device 4956 such that theaudible output device 4956 outputs an audible output that has a soundpressure level greater than about 61 dB. In yet other embodiments, theaudible output can have a sound pressure level greater than about 61 dBat a distance of about 6 inches from the audible output device 4956. Inyet other embodiments, the audible output can have a sound pressurelevel greater than about 61 dB within a distance of about 20 feet fromthe audible output device 4956.

In some embodiments, the processor 4950 can output an electronic outputhaving a power of less than 100 milliwatts (mW) to the audible outputdevice 4956, and the audible output device 4956 can output an audibleoutput that has a sound pressure level greater than about 61 dB. In yetanother embodiment, the electronic output can have a power of less than100 mW and the audible output can have a sound pressure level greaterthan about 61 dB at a distance of about 6 inches from the audible outputdevice 4956. In yet another embodiment, the electronic output can have apower of less than 100 mW and the audible output can have a soundpressure level greater than about 61 dB within a distance of about 20feet from the audible output device 4956.

In other embodiments, the medicament delivery device (or medicalinjector) 4000 can have a network interface device (not shown)configured to operatively connect the electronic circuit system 4900 toa remote device (not shown) and/or a communications network (not shown).In this manner, the electronic circuit system 4900 can send informationto and/or receive information from the remote device. The remote devicecan be, for example, a remote communications network, a computer, acompliance monitoring device, a cell phone, a personal digital assistant(PDA) or the like. Such an arrangement can be used, for example, todownload replacement processor-readable code from a central network tothe electronic circuit system 4900. In some embodiments, for example,the electronic circuit system 4900 can download information associatedwith the medicament delivery device 4000, such as an expiration date, arecall notice, updated use instructions or the like. Similarly, in someembodiments, the electronic circuit system 4900 can upload complianceinformation associated with the use of the medicament delivery device4000 via the network interface device.

FIGS. 22 and 23 show the cover 4200 of the medicament delivery device4000. The cover 4200 includes a proximal end portion 4210 and a distalend portion 4230, and defines a cavity 4242. The cavity 4242 of thecover 4200 is configured to receive at least a portion of the housing4110. The proximal end portion 4210 defines apertures 4215 configured toreceive the cover retention protrusions 4142 of the housing 4110 (shownin FIGS. 4B and 6). In this manner, the apertures 4215 and the coverretention protrusions 4142 of the housing 4110 removably retain thecover 4200 about at least a portion of the housing 4110. Said anotherway, the apertures 4215 and the cover retention protrusions 4142 of thehousing 4110 are configured such that the cover 4200 can be removed froma portion of the housing 4110 and then replaced about the portion of thehousing 4110.

The distal end portion 4230 of the cover 4200 includes a batteryisolation protrusion 4235. The battery isolation protrusion 4235includes a proximal end portion 4236 and a tapered portion 4237. Theproximal end portion 4236 of the battery isolation protrusion 4235 isconfigured to be removably disposed between the second surface 4966 ofthe battery assembly 4962 and the contact portion 4918 of the distal endportion 4916 of the battery clip 4910, as described above. When thebattery isolation protrusion 4235 is removed, the opening or portassociated with the battery isolation protrusion aperture 4121 is openedsuch that sound waves produced by the audible output device 4956 withinthe electronic circuit system cavity 4153 can exit the electroniccircuit system cavity 4153 to an area outside the housing 4110.

FIGS. 22-23 show the safety lock 4700 of the medicament delivery device4000. The safety lock 4700 of the medicament delivery device 4000includes a proximal surface 4740, a distal surface 4760 opposite theproximal surface 4740 and a needle sheath 4720. The safety lock 4700defines a needle sheath aperture 4770 and a battery isolation protrusionaperture 4775. The battery isolation protrusion aperture 4775 isconfigured to receive the battery isolation protrusion 4235 of the cover4200 such that the battery isolation protrusion 4235 can be disposedwithin the electronic circuit system cavity 4153 or the electroniccircuit system 4900, as described above. Similarly stated, the batteryisolation protrusion aperture 4775 of the safety lock 4700 is alignedwith the battery isolation protrusion aperture 4121 of the housing 4110,such that the battery isolation protrusion 4235 can be disposed withinthe electronic circuit system cavity 4153 when the cover 4200 isdisposed about a portion of the housing 4110. The battery isolationprotrusion aperture 4775 is aligned with the battery isolationprotrusion aperture 4121 such that sound waves produced by the audibleoutput device 4956 within the electronic circuit system cavity 4153 thatexit through the battery isolation protrusion aperture 4121 can travelthrough the battery isolation protrusion aperture 4775.

The proximal surface 4740 of the safety lock 4700 includes a safety lockprotrusion 4742, a stopper 4743, an actuator 4744 and two opposing pulltabs 4741. As described above, when the safety lock 4700 is in a first(locked) position, the safety lock protrusion 4742 is configured to bedisposed in the opening 4554 defined by the extensions 4552 of thedistal end portion 4544 of the release member 4540. Accordingly, thesafety lock protrusion 4742 is configured to prevent the extensions 4552from moving closer to each other, thereby preventing proximal movementof the release member 4540 of the medicament delivery mechanism 4500and/or delivery of a medicament. The stopper 4743 of the safety lock4700 is a protrusion extending from the proximal surface 4740 of thesafety lock 4700. The stopper 4743 is configured to contact a portion ofthe housing 4110 to limit the proximal movement of the safety lock 4700relative to the housing 4110. In other embodiments, the stopper 4743 canbe any structure configured to limit the proximal movement of the safetylock 4700.

The actuator 4744 of the safety lock 4700 has an elongated portion 4745and a protrusion 4746. The elongated portion 4745 extends in a proximaldirection from the proximal surface 4740. In this manner, the elongatedportion 4745 can extend through a safety lock actuator opening 4356 ofthe base 4300 (see e.g., FIG. 26). The protrusion 4746 extends in adirection substantially transverse to the elongated portion 4745 and/orsubstantially parallel to the proximal surface 4740 of the safety lock4700. The pull tabs 4741 of the safety lock 4700 include a grip portion4747 and indicia 4748. The grip portion 4747 of the pull tabs 4741provides an area for the user to grip and/or remove the safety lock 4700from the rest of the medicament delivery device 4000. The indicia 4748provide instruction on how to remove the safety lock 4700.

As shown in FIG. 25, the needle sheath 4720 of the safety lock 4700includes a distal end portion 4724, a proximal end portion 4722 and aplurality of ribs 4728. The needle sheath 4720 can also define a lumen4729 configured to receive the needle 4512. In this manner, the needlesheath 4720 can protect the user from the needle 4512 and/or can keepthe needle 4512 sterile before the user uses the medicament deliverydevice 4000. The distal end portion 4724 of the needle sheath 4720 hasan angled ridge 4725. The angled ridge 4725 is configured to allow theproximal end portion 4722 of the needle sheath 4720 to irreversibly movethrough the needle sheath aperture 4770 of the safety lock 4700 in adistal direction. The needle sheath aperture 4770 has retaining tabs4771 configured to prevent the proximal movement of the needle sheathwith respect to the safety lock 4700. As shown in FIG. 28, the needlesheath 4720 is removed from the needle 4512 when the safety lock 4700 ismoved in a distal direction with respect to the housing 4110.

FIGS. 24A and 24B show the base 4300 of the medicament delivery device4000. The base 4300 includes a proximal surface 4310, a distal surface4330 and base connection knobs 4358. The base 4300 defines a needleaperture 4350, a safety lock protrusion aperture 4352, a batteryisolation protrusion aperture 4354, a safety lock actuator opening 4356,and pull tab openings 4360. The needle aperture 4350 is configured toreceive the needle 4512 when the medical injector 4000 is actuated. Thesafety lock protrusion aperture 4352 of the base 4300 receives thesafety lock protrusion 4742 of the safety lock 4700. The batteryisolation protrusion aperture 4354 of the base 4300 receives the batteryisolation protrusion 4235 of the cover 4200 and the stopper 4743 of thesafety lock 4700. The safety lock actuator opening 4356 receives thesafety lock actuator 4744 of the safety lock 4700. The pull tab openings4360 are configured to receive the pull tabs 4741 of the safety lock4700.

The battery isolation protrusion aperture 4354 is aligned with thebattery isolation protrusion aperture 4121 such that sound wavesproduced by the audible output device 4956 within the electronic circuitsystem cavity 4153 that exit through the battery isolation protrusionaperture 4121 can travel through the battery isolation protrusionaperture 4354.

The proximal surface 4310 of the base 4300 includes an actuator 4311,and protrusions 4313. The actuator 4311 is an elongate member configuredto engage the substrate 4924 of the electronic circuit system 4900. Theprotrusions 4313 of the base 4300 are configured to engage the taperedsurfaces 4549 of the extensions 4552 of the release member 4540. Asdescribed in further detail herein, when the safety lock 4700 is removedand the base 4300 is moved in a proximal direction with respect to thehousing 4110, the protrusion 4313 of the base 4300 are configured tomove the extensions 4552 of the release member 4540 closer to eachother, actuating the medicament delivery mechanism 4500. As describedabove, the base connection knobs 4358 are configured to engage the baseretention recesses 4125A, 4125B in a way that allows proximal movementof the base 4300 but limits distal movement of the base 4300.

As shown in FIG. 27, the medicament delivery device 4000 is firstenabled by moving the medicament delivery device 4000 from a firstconfiguration to a second configuration by moving the cover 4200 from afirst position to a second position. The cover 4200 is moved from thefirst position to the second position by moving it with respect to thehousing 4110 in the direction shown by the arrow CC in FIG. 27. When thecover 4200 is moved with respect to the housing 4110 in the directionCC, the battery isolation protrusion 4235 is removed from the areabetween the battery clip 4910 and the second surface 4966 of the batteryassembly 4962. In this manner, the battery assembly 4962 can beoperatively coupled to the electronic circuit system 4900 when the cover4200 is removed, thereby providing power to the electronic circuitsystem 4900.

When power is provided, as described above, the electronic circuitsystem 4900 can output one or more predetermined electronic outputsand/or audible outputs. For example, in some embodiments, the electroniccircuit system 4900 can output an electronic signal associated withrecorded speech to the audible output device 4956 such that the audibleoutput device 4956 outputs an audible output. Such an electronic signalcan be, for example, associated with a .WAV file that contains arecorded instruction instructing (e.g., prompting) the user in theoperation of the medicament delivery device 4000. Such an instructioncan state, for example, “remove the safety tab near the base of theauto-injector.” The electronic circuit system 4900 can simultaneouslyoutput an electronic signal to one and/or both of the LEDs 4958A, 4958Bthereby causing one and/or both of the LEDs 4958A, 4958B to flash aparticular color. In this manner, the electronic circuit system 4900 canprovide both audible and visual instructions to assist the user in theinitial operation of the medical injector 4000. Further, because thebattery isolation protrusion 4235 has been removed from the batteryisolation protrusion aperture 4121, an audible output by the audibleoutput device 4956 can include sound waves produced within theelectronic circuit system cavity 4153 that exit through the batteryisolation protrusion aperture 4121.

In other embodiments, the electronic circuit system 4900 can output anelectronic output and/or an audible output associated with a descriptionand/or status of the medicament delivery device 4000 and/or themedicament contained therein. For example, in some embodiments, theelectronic circuit system 4900 can output an audible message indicatingthe type of medicament contained in the medicament delivery device 4000,the expiration date of the medicament, the dosage of the medicament orthe like. Such an audible message can state, for example, “You haveremoved an auto-injector containing DOSE mg of Epinephrine. Theexpiration date of this device is EXPIRATION DATE. If the current dateis later than EXPIRATION DATE, please select another auto-injector.” Inother embodiments, for example, the audible message can be a messageproviding the user with use instructions or other information that isuniquely associated with the medicament delivery device 4000. Forexample, such a message can prompt a user to call a phone number uniqueto the manufacturer of the medicament delivery device 4000 forassistance before, during or after the use of the medicament deliverydevice 4000. In yet other embodiments, an electronic circuit system canautomatically call such a phone number when the medicament deliverydevice 4000 is removed from its container.

As described above, the medicament delivery device 4000 can berepeatedly moved between the first configuration and the secondconfiguration when the cover 4200 is moved repeatedly between the firstposition and the second position respectively. Said another way, thecover 4200 can be removed and replaced about the housing 4110 any numberof times. When the cover 4200 is moved from the second position to thefirst position, the battery isolation protrusion 4235 is insertedbetween the battery clip 4910 and the second surface 4966 of the batteryassembly 4962, deactivating the electronic circuit system 4900 andclosing the acoustic port associated with the battery isolationprotrusion aperture 4121. When the cover is moved from the firstposition to the second position a second time, the electronic circuitsystem 4900 is once again activated and the acoustic port is opened. Inthis manner, the cover 4200 can be removed and the electronic circuitsystem 4900 can output an electronic output without compromising thesterility of the needle 4512.

After the cover 4200 is removed from the housing 4110, the medicamentdelivery device 4000 can be moved from the second configuration to athird configuration by moving the safety lock 4700 from a first positionto a second position. The safety lock 4700 is moved from a firstposition to a second position by moving the safety lock 4700 withrespect to the housing 4110 in the direction shown by the arrow DD inFIG. 28. When the safety lock 4700 is moved from the first position tothe second position, the safety lock protrusion 4742 is removed frombetween the extensions 4552 of the release member 4540, thereby enablingthe medicament delivery mechanism 4500. When the actuator 4744 of thesafety lock 4700 moves irreversibly the first switch 4972 of theelectronic circuit system 4900 to the second state, the electroniccircuit system 4900 can output one or more predetermined electronicoutputs and/or audible outputs. For example, in some embodiments, aprocessor (not shown) can output an electronic signal associated withrecorded speech to the audible output device 4956. Such an electronicsignal can be, for example, associated with a recorded message notifyingthe user of the status of the medicament delivery device 4000. Such astatus message can state, for example, “The medical injector is nowenabled.” The electronic circuit system 4900 can also simultaneouslyoutput an electronic signal to one and/or both of the LEDs 4958A, 4958B,thereby causing one and/or both of the LEDs 4958A, 4958B to stopflashing, change color, produce a particular lighting sequence, or thelike.

In some embodiments, the first actuation portion 4926 and the actuator4744 can be configured such that the actuator 4744 must move apredetermined distance before the actuator 4744 engages the boundary4929 of the opening 4928. For example, in some embodiments, the actuator4744 must move approximately 0.200 inches before the actuator 4744engages the boundary 4929 of the opening 4928. In this manner, thesafety lock 4700 can be moved slightly without irreversibly moving thefirst switch 4972 of the electronic circuit system 4900 to the secondstate. Accordingly, this arrangement will permit the user toinadvertently and/or accidentally move the safety lock 4700 withoutactuating the electronic circuit system 4900.

Although the switches (e.g., the first switch 4972 and the second switch4973) are shown and described as being monolithically formed from anelectrical conductor (see, e.g., FIG. 15), in other embodiments, aswitch can be formed separately from the electrical conductors. Forexample, in some embodiments, an electrical circuit system can include aseries of first electrical conductors having a first set ofcharacteristics (e.g., the width, height, material from which theconductor is fabricated or the like) and a switch constructed from asecond electrical conductor having a second set of characteristicsdifferent than the first set of characteristics. In other embodiments, aswitch can be a separate component, such as, for example, a microswitch,that is mounted to the printed circuit board. In yet other embodiments,an electrical circuit system can include a “pop-out” switch thatincludes a biasing member to bias the switch in a predetermined state.In yet other embodiments, an electrical circuit system can include aswitch that is disposed at a location other than on a printed circuitboard.

Similarly, although the switches (e.g., the first switch 4972 and thesecond switch 4973) are shown and described as being irreversiblymovable from a first state to a second state, in other embodiments, aswitch can be reversibly movable between a first state and a secondstate. Moreover, in yet other embodiments, a switch can have more thantwo distinct states.

In some embodiments, the electronic circuit system 4900 can beconfigured to output the status message for a predetermined time period,such as, for example, five seconds. After the predetermined time periodhas elapsed, the electronic circuit system 4900 can output an audiblemessage further instructing the user in the operation of the medicamentdelivery device 4000. Such an instruction can state, for example, “Placethe base of the auto-injector against the patient's thigh. To completethe injection, press the base firmly against the patient's thigh.” Insome embodiments, the electronic circuit system 4900 can simultaneouslyoutput an electronic signal to one and/or both of the LEDs 4958A, 4958B,thereby causing one and/or both of the LEDs 4958A, 4958B to flash aparticular color and/or produce a particular lighting sequence. In thismanner, the electronic circuit system 4900 can provide both audibleand/or visual instructions to assist the user in the placement andactuation of the medicament delivery device 4000. In some embodiments,the electronic circuit system 4900 can be configured to repeat theinstructions after a predetermined time period has elapsed.

As described above, in other embodiments, the medical injector 4000 canhave a network interface device (not shown) configured to operativelyconnect the electronic circuit system 4900 to a remote device (notshown) and/or a communications network (not shown). In this manner, theelectronic circuit system 4900 can send a wireless signal notifying aremote device that the safety lock 4700 of the medical injector 4000 hasbeen removed and that the medical injector 4000 has been armed.

After the safety lock 4700 is moved from the first position to thesecond position, the medicament delivery device 4000 can be moved fromthe third configuration to a fourth configuration by moving the base4300 from a first position to a second position. The base 4300 is movedfrom its first position to its second position by placing the medicamentdelivery device 4000 against the body of the patient and moving the base4300 with respect to the housing 4110 in the direction shown by thearrow EE in FIG. 29. Moving the base 4300 from the first position to thesecond position causes the protrusions 4313 on the proximal surface 4310of the base 4300 to engage the tapered surfaces 4549 of the extensions4552 of the release member 4540, causing the release member 4540 toactuate the medicament delivery mechanism 4500 and deliver a medicamentto a body of a patient.

When the base 4300 is moved from the first position to the secondposition, the medicament delivery mechanism 4500 is actuated such thatthe puncturer 4541 of the release member 4540 is brought in contact withand/or punctures the frangible seal 4573 of the gas container 4570. Insome embodiments, the movement of the release member 4540 can be causedby a spring (not shown in FIG. 12). After the frangible seal 4573 hasbeen punctured, an actuating portion of a compressed gas can escape fromthe gas container 4570 and flow via the gas passageway 4144 into themedicament cavity 4157. The gas applies gas pressure to the movablemember 4530 causing the movable member 4530 and the carrier 4520 to movein a distal direction within the medicament cavity 4157. When thecarrier 4520 moves distally within the medicament cavity 4157, thecarrier 4520 and the medicament container 4560 are in a firstconfiguration. Accordingly, as described above, the medicament container4560 is connected to the carrier 4520 by a “snap fit” connection. Inthis manner, the medicament container 4560 and the needle 4512contemporaneously move with movable member 4530 and/or the carrier 4520in a distal direction. As described above, the proximal end portion 4516of the needle 4512 is connected to the distal end portion 4522 of thecarrier 4520 and is spaced from the seal 4523 of the medicamentcontainer 4560 when the carrier 4520 is in its first configuration. Saidanother way, the medicament container 4560 and the needle 4512 do notdefine a medicament delivery path when the carrier 4520 is in the firstconfiguration. The movement of the needle 4512 in a distal directioncauses a distal end portion 4514 of the needle 4512 to exit the housing4110 and enter the body of a patient prior to administering amedicament.

After the carrier 4520 and/or the needle 4512 have moved within themedicament cavity 4157 a predetermined distance, the carrier 4520 andthe medicament container 4560 are moved from the first configuration toa second configuration. In the second configuration of the carrier 4520,the medicament container 4560 is released from the “snap-fit” allowingthe medicament container 4560 and the movable member 4530 to continue tomove in a distal direction relative to the carrier 4520. Said anotherway, the medicament container 4560 is configured to slidably move withinthe carrier 4520 when the carrier is moved from the first configurationto the second configuration. As the medicament container 4560 continuesto move within the carrier 4520, the proximal end portion 4516 of theneedle 4512 contacts and punctures the seal 4523 of the medicamentcontainer 4560. This allows the medicament contained in the medicamentcontainer 4560 to flow into the lumen (not shown) defined by the needle4512, thereby defining a medicament delivery path.

As the medicament container 4560 contacts the distal end of the carrier4520, the medicament container 4560 stops moving within the carrier 4520while the movable member 4530 continues to move in a distal direction.This causes the piston portion 4534 of the movable member 4530 tosealingly slide and/or move within the medicament container 4560containing a liquid medicament. As the piston portion 4534 of themovable member 4530 sealingly slides and/or moves within the medicamentcontainer 4560, the piston portion 4534 generates a pressure upon themedicament contained within the medicament container 4560, therebyallowing at least a portion of the medicament to flow out of themedicament container 4560 and into the lumen defined by the needle 4512.The medicament is delivered to a body of a user via the medicamentdelivery path defined by the medicament container 4560 and the needle4512.

As described above, the actuator 4311 of the base 4300 actuates theelectronic circuit 4900 to trigger a predetermined output or sequence ofoutputs when the base 4520 is moved from its first position to itssecond position (see, e.g., FIG. 21). When the actuator 4311 is moved ina proximal direction, the electronic circuit system 4900 is actuated tooutput one or more predetermined electronic outputs and/or audibleoutputs. For example, in some embodiments, the electronic circuit system4900 can output an electronic signal associated with recorded speech tothe audible output device 4956. Such an electronic signal can be, forexample, associated with an audible countdown timer, instructing theuser on the duration of the injection procedure. Said another way, if ittakes, for example, ten seconds to complete an injection, an audiblecountdown timer can count from ten to zero ensuring that the usermaintains the medicament delivery device 4000 in place for the full tenseconds. In other embodiments, the electronic signal can be, forexample, associated with a recorded message notifying the user that theinjection is complete, instructing the user on post-injection disposaland safety procedures, instructing the user on post-injection medicaltreatment or the like. Such a status message can state, for example,“The injection is now complete. Please seek further medical attentionfrom a doctor.” The electronic circuit system 4900 can alsosimultaneously output an electronic signal to one and/or both LEDs4958A, 4958B, thereby causing one and/or both LEDs 4958A, 4958B to stopflashing, change color, produce a particular lighting sequence, or thelike, to provide a visual indication that the injection is complete. Inother embodiments, the electronic circuit system 4900 can send awireless signal notifying a remote device that the injection iscomplete. In this manner, a patient's compliance can be monitored.

Although the housing 4110 is shown and described above as defining theelectronic circuit system cavity 4153, in other embodiments, the housing4110 need not define the electronic circuit system cavity 4153. Forexample, in some embodiments, the electronic circuit system assembly caninclude a housing that defines a cavity and/or an acoustic enclosurewithin which a speaker is disposed. For example, FIGS. 30-32 areschematic illustrations of medicament delivery device 5000 and anelectronic circuit system assembly 5900 according to an embodiment. Themedicament delivery device 5000 can be any suitable device fordelivering a medicament into a body of a patient. For example, themedicament delivery device 5000 can be an inhaler, a medical injector(e.g., a syringe, pen injector, auto-injector, or the like), atransdermal medicament delivery system or the like. The medicamentdelivery device 5000 includes a housing 5110 containing a medicamentcontainer (not shown in FIGS. 30-32) and/or a medicament deliverymechanism (not shown in FIG. 30-32) for delivering the medicament intothe body.

As shown in FIGS. 30 and 31, the electronic circuit system assembly 5900is configured to be coupled to the housing 5110 of the medicamentdelivery device 5000. In some embodiments, for example, the electroniccircuit system assembly 5900 can be configured to be coupled to aparticular medicament delivery device as a kit (e.g., a retrofit kit).In other embodiments, the electronic circuit system assembly 5900 can beconfigured to be coupled to multiple different medicament deliverydevices. Similarly stated, in some embodiments, the electronic circuitsystem assembly 5900 can be a part of a “universal” retrofit kit. Asdescribed above, the electronic circuit system 5900 is configured toproduce and/or output an audible output associated with a use of themedicament delivery device 5000.

The electronic circuit system assembly 5900 includes at least a housing5170, a printed circuit board 5922, and a speaker 5956. The printedcircuit board 5922 includes electronic components (e.g., a processor, abattery assembly, or the like; not shown in FIGS. 30-32) operativelycoupled to produce and/or output an audible output. The printed circuitboard 5922, the speaker 5956 and the associated electronic componentscan be similar to those included in the electronic circuit system 4900shown and described above.

The housing 5170 of the electronic circuit system assembly 5900 includesa side wall 5159 that defines a cavity 5158, an end opening 5174 andmultiple sound apertures 5191. As shown in FIG. 32 the printed circuitboard 5922 and the speaker 5956 are coupled to the housing 5170 of theelectronic circuit system assembly 5900 within the cavity 5158. Inparticular, the speaker 5956 is disposed against the side wall 5159 suchthat a first side (e.g., a front side) of the speaker 5956 is disposedadjacent the sound apertures 5191. In this manner, sound waves from thefirst side of speaker 5956 can travel from the speaker 5956 to a regionoutside of the housing 5170 of the electronic circuit system assembly5900 via the sound apertures 5191.

The housing 5170 of the electronic circuit system assembly 5900 iscoupled to the housing 5110 of the medicament delivery device 5000, asshown by the arrow FF in FIG. 30. The housing 5170 can be coupled to thehousing 5110 by any suitable mechanism (e.g., by mating protrusions andrecesses, by heat staking, using an adhesive bond, or the like). Asshown in FIG. 32, the housing 5110 of the medicament delivery device5000 and the cavity 5158 of the housing 5170 of the electronic circuitsystem assembly 5900 collectively define an acoustic enclosure withinwhich the speaker 5956 is disposed. Said another way, a surface 5148 ofthe housing 5110 and the side wall 5159 collectively define the boundaryof a region, volume and/or space that is configured to minimize orattenuate noise and/or enhance the audible output of the speaker 5956,in a manner as described above. Moreover, the opening 5174 can functionas a port to allow sound waves produced by a second side (e.g., a backside) of the speaker 5956 to exit the cavity 5158 of the housing 5170 toan area outside the housing 5170. As described above, the opening 5174can be spaced a predetermined distance from the speaker 5956 to enhancethe quality of the audible output produced by the speaker 5956.

Because the electronic circuit system 5900 includes the electroniccomponents (e.g., a processor configured to produce an electronicsignal, the speaker 5956 and the like) and defines the cavity 5158, theelectronic components and the cavity 5158 can be complimentarilyselected and/or configured to enhance the quality of the audible outputproduced by the speaker 5956. Similarly stated, this arrangement allowsthe sound performance of the electronic circuit system 5900 to beoptimized substantially independent of the housing 5110 of themedicament delivery device 5900.

Although the acoustic enclosure is shown as being defined, in part, by asurface 5148 of the housing 5110 of the medicament delivery device 5000,in other embodiments, the housing 5170 of the electronic circuit systemassembly 5900 can define a substantially enclosed cavity 5158 configuredto function as an acoustic chamber. In some embodiments, for example, ahousing 5170 can include a sidewall configured to be disposed against aportion of the medicament delivery device 5000 and define a boundary ofan acoustic enclosure. In such embodiments, the side wall can be anysuitable side wall for coupling the housing 5170 of the electroniccircuit system assembly 5900 to the medicament delivery device 5000and/or enhancing the audible output produced by the speaker 5956. Forexample, the side wall can be an elastic side wall. In otherembodiments, the side wall can be a porous side wall.

Although the cavity 5158 of the housing 5170 of the electronic circuitsystem assembly 5900 is shown as being disposed adjacent the medicamentdelivery device 5000, in some embodiments, a portion of the medicamentdelivery device can be disposed within the cavity. For example, in someembodiments, the electronic circuit system assembly can be disposedabout a portion of the medicament delivery device.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although the audio output device 4956 is shown anddescribed as having front portion 4957 configured to produce a first setof sound waves and a back portion 4955 opposite the front portionconfigured to produce a second set of sound waves, in other embodiments,an audio device can have a first portion configured to produce a firstset of sound waves and a second portion configured to produce a secondset of sound waves wherein the first portion is not opposite the secondportion. For example, in some embodiments, an audio output device canhave a first surface configured to produce a first set of sound wavesand a second surface adjacent and/or in contact with the first surface,the second surface configured to produce a second set of sound waves.

Although the electronic circuit system cavity 4153 is shown as defininga substantially rectangular acoustic enclosure, in some embodiments, amedicament delivery device can define an acoustic enclosure having anysuitable shape. For example, in some embodiments, a medicament deliverydevice can define a substantially cylindrical acoustic enclosure.

The electronic circuit system cover 4170 is matingly coupled to thehousing 4110 such that the electronic circuit system cover 4170 and theelectronic circuit system cavity 4153 collectively define an acousticenclosure within which the audible output device 4956 is disposed. Saidanother way, the electronic circuit system cover 4170 and the electroniccircuit system cavity 4153 collectively form a region, volume and/orspace that is configured to minimize or attenuate noise and/or enhancethe audible output of the audible output device 4956. Moreover, thevolume associated with the region defined by the electronic circuitsystem cover 4170 and the electronic circuit system cavity 4153 islarger than the volume of the audible output device 4956 and/or theelectronic circuit system 4900 disposed within the region. In thismanner, the acoustic enclosure defined by the electronic circuit systemcover 4170 and the electronic circuit system cavity 4153 is configuredto contain a volume of air behind the audible output device 4956.

Although the electronic circuit system cavity 4153 is shown as definingthe acoustic enclosure, in other embodiments, a medicament deliverydevice can define an acoustic enclosure that is separate from a cavitywithin which a portion of the electronic circuit system is disposed. Insome embodiments, for example a housing can define a first cavity withinwhich a printed circuit board of an electronic circuit system isdisposed and a second cavity distinct from the first cavity within whicha portion of an audio output device is disposed. The first cavity caninclude, for example, potting material to enhance the reliability and/orperformance of the printed circuit board. The second cavity can bedevoid of internal structure and can function as an acoustic enclosure.

Although the electronic circuit system cavity 4153 is shown anddescribed as being substantially devoid of structure, in otherembodiments, an electronic circuit system cavity can include componentstherein to enhance the performance of the cavity as an acousticenclosure. For example, in some embodiments, an electronic circuitsystem cavity can include a set of baffles. In this manner, the lengththrough which sound waves produced by a back portion of an audio outputdevice can be increased to a value greater than an overall length of theelectronic circuit system cavity.

Although the electronic circuit system cavity 4153 is shown anddescribed as having a single “port” (i.e., the battery isolationprotrusion aperture 4121) disposed at the distal end thereof, in otherembodiments, an electronic circuit system cavity 4153 can include a portdisposed in any suitable location. For example, in some embodiments, anelectronic circuit system cavity can include a port disposed at theproximal end thereof. Moreover, in some embodiments, an electroniccircuit system cavity 4153 can include multiple openings at multipledifferent locations.

While the housing shown in the current embodiment is rigid, a portion ofthe housing can be made flexible such that the flexible portion of thehousing operates as a passive counterpart to the active operation of theaudible output device. In such embodiment, the flexible portion of thehousing can dynamically adjust the acoustic enclosure size and/or shapeto improve the sound pressure level produced by the audible outputdevice. For example, in some embodiments, the sidewall of the housingthat defines a portion of an acoustic enclosure can be a movable membersuch as, for example, a piston. In yet other embodiments, the sidewallcan be a flexible member such as, for example, a diaphragm. The sidewallcan be integrally formed with the housing or can be separately formed.

Although the battery assembly 4962 is shown and described as includingtwo batteries stacked on top of one another, in other embodiments, abattery assembly can include two or more batteries that are not arrangedin a stacked fashion. For example, in some embodiments, a batteryassembly can include two or more batteries that are arranged end-to-endsuch that an edge of one battery is in contact with an edge of anotherbattery. In other embodiments, a battery assembly can include two ormore batteries that are spaced apart from each other. Similarly,although the battery clip 4910 is shown and described as having a singlecontact portion 4918 at the distal end thereof, in other embodiments(e.g., embodiments in which the battery assembly includes batteries inan unstacked relationship), a battery clip can include more than onecontact portion.

Although the battery assembly 4962 is shown and described above asincluding three volt, “watch-style” batteries, in other embodiments, theelectronic circuit system 4900 can be powered by any suitable powersource. For example, in some embodiments, the battery assembly 4962 caninclude one or more rechargeable batteries. Such an arrangement iswell-suited for multiple-use medicament delivery devices (e.g.,chronic-care devices). In other embodiments, an electronic circuitsystem can be devoid of a battery assembly 4962. Said another way, insome embodiments, electrical power can be provided to an electroniccircuit system by a source other than batteries (e.g., a solar powersupply, a capacitance-based power supply, a bio-active power supply thatproduces electricity by breaking down organic materials, a small-scalemechanical generator, a small-scale fuel cell or the like).

Although the medicament delivery device 4000 is shown and described asbeing an actual medicament delivery device, in some embodiments, thehousing 4110 and/or the electronic circuit system 4900 can be associatedwith a simulated medicament delivery device. Such simulated devices canbe devoid of medicament and/or needles, and can be used, for example, totrain users in the operation of a corresponding actual medicamentdelivery device.

The simulated medicament delivery device can include an electroniccircuit system configured to output an electronic output associated withthe use of the simulated medicament delivery device. As describedherein, in some embodiments, for example, the electronic output can beassociated with an identification of the simulated medicament deliverydevice, an identification of certain components of the simulatedmedicament delivery device (e.g., a top portion, a safety lock, or thelike), an identification of a physical condition for which a patient mayrequire the medicament delivery device and/or an instruction for usingthe simulated medicament delivery device and/or the corresponding actualmedicament delivery device.

Moreover, the electronic output can include any type of electronicoutput and/or signal discussed herein, such as, for example, a visualoutput, an audible output and/or a haptic output. For example, in someembodiments, the electronic output can be a signal associated with anaudible message (e.g., recorded speech) identifying the simulatedmedicament delivery device. Such an audible message can state, forexample, “You have removed an auto-injector trainer that will teach youhow to use an actual auto-injector. This trainer does not contain anymedicament. If this is an actual emergency, please dial 911 or locate anactual auto-injector.” In some embodiments, an audible output caninstruct a user in the use of the simulated medicament delivery device.Such an audible message can state, for example, “The first step in usingan actual auto-injector is to identify the key features of theauto-injector. The key features of the auto-injector are the safety lockand the actuator button . . . . ” In other embodiments, the electronicoutput can be associated with a visual indicator that identifies one ormore components of the simulated medicament delivery device.

The simulated medicament delivery device can simulate the actualmedicament delivery device in any number of ways. For example, in someembodiments, the simulated medicament delivery device can have a shapecorresponding to a shape of the actual medicament delivery device, asize corresponding to a size of the actual medicament delivery deviceand/or a weight corresponding to a weight of the actual medicamentdelivery device. Moreover, in some embodiments, the simulated medicamentdelivery device can include components that correspond to the componentsof the actual medicament delivery device. In this manner, the simulatedmedicament delivery device can simulate the look, feel and sounds of theactual medicament delivery device. For example, in some embodiments, thesimulated medicament delivery device can include external components(e.g., a housing, a needle guard, a sterile cover, a safety lock or thelike) that correspond to external components of the actual medicamentdelivery device. In some embodiments, the simulated medicament deliverydevice can include internal components (e.g., an actuation mechanism, aspring, a compressed gas source, a medicament container or the like)that correspond to internal components of the actual medicament deliverydevice.

In some embodiments, however, the simulated medicament delivery devicecan be devoid of a medicament and/or those components that cause themedicament to be delivered (e.g., a needle, a nozzle or the like). Inthis manner, the simulated medicament delivery device can be used totrain a user in the use of the actual medicament delivery device withoutexposing the user to a needle and/or a medicament. Moreover, thesimulated medicament delivery device can have features to identify it asa training device to prevent a user from mistakenly believing that thesimulated medicament delivery device can be used to deliver amedicament. For example, in some embodiments, the simulated medicamentdelivery device can be of a different color than a corresponding actualmedicament delivery device. Similarly, in some embodiments, thesimulated medicament delivery device can include a label clearlyidentifying it as a training device.

In some embodiments, the simulated medicament delivery device canrepeatedly simulate the actual medicament delivery device. In thismanner, the simulated medicament delivery device can be configured torepeat the electronic output or predetermined sequence of electronicoutputs during subsequent simulations.

Although the simulated medicament delivery device is described asincluding external components and/or internal components to simulateactual medicament delivery devices, in some embodiments, a simulatedmedicament delivery device can be devoid of certain components, such as,for example, springs, actuation mechanisms or the like. For example, insome embodiments, a simulated medicament delivery device can include anelectronic circuit system configured to output an electronic output tosimulate any one of a tactile sensation, an audible sensation, a visualsensation, an olfactory sensation and/or a taste sensation associatedwith a use of the medicament delivery device. In this manner, thesimulated medicament delivery device can simulate a medicament deliverydevice without mechanical components and/or medicament, which can bemake the simulated medicament delivery device expensive, unsafe to use,difficult to use, difficult to reset for repeated use or the like.

Some embodiments include a processor and a related processor-readablemedium having instructions or computer code thereon for performingvarious processor-implemented operations. Such processors can beimplemented as hardware modules such as embedded microprocessors,microprocessors as part of a computer system, Application-SpecificIntegrated Circuits (“ASICs”), and Programmable Logic Devices (“PLDs”).Such processors can also be implemented as one or more software modulesin programming languages as Java, C++, C, assembly, a hardwaredescription language, or any other suitable programming language.

A processor according to some embodiments includes media and computercode (also can be referred to as code) specially designed andconstructed for the specific purpose or purposes. Examples ofprocessor-readable media include, but are not limited to: magneticstorage media such as hard disks, floppy disks, and magnetic tape;optical storage media such as Compact Disc/Digital Video Discs(“CD/DVDs”), Compact Disc-Read Only Memories (“CD-ROMs”), andholographic devices; magneto-optical storage media such as opticaldisks, and read-only memory (“ROM”) and random-access memory (“RAM”)devices. Examples of computer code include, but are not limited to,micro-code or micro-instructions, machine instructions, such as producedby a compiler, and files containing higher-level instructions that areexecuted by a computer using an interpreter. For example, an embodimentof the invention can be implemented using Java, C++, or otherobject-oriented programming language and development tools. Additionalexamples of computer code include, but are not limited to, controlsignals, encrypted code, and compressed code.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, although the medicamentdelivery device 4000 is shown and described as including an electroniccircuit system cavity 4153 that can function as an acoustic enclosureand an electronic circuit system devoid of a signal amplifier, in otherembodiments, a medicament delivery device can include an acousticenclosure and an electronic circuit system having a signal amplifier. Insuch embodiments, for example, the electronic signal produced by aprocessor (which can have a power of less than 100 milliwatts) can beamplified to provide an input signal to a speaker having a power levelof greater than the power level of the signal produced by the processor.

What is claimed is:
 1. A method, comprising: removing a distal endportion of a medical injector from within an outer case, the medicalinjector including a housing, an actuator, a locking member, and anelectronic circuit system, the locking member in contact with theactuator to limit movement of the actuator when the locking member is ina first position, the electronic circuit system including an outputdevice and a network interface device, the outer case including aprotrusion disposed within the housing and in contact with theelectronic circuit system when the distal end portion of the medicalinjector is within the outer case, the protrusion disposed outside ofthe housing when the distal end portion of the medical injector isoutside of the outer case, the electronic circuit system producing afirst output via the output device in response to the protrusion beingspaced apart from the electronic circuit system when the distal endportion of the medical injector is removed from within the outer case,moving the locking member from the first position to a second position,the locking member spaced apart from the actuator when the lockingmember is in the second position; and moving the actuator to initiatedelivery of a medicament from the medical injector, the electroniccircuit system producing a second output via the output device inresponse to the moving the actuator, the network interface devicetransmitting a wireless signal to a remote device, the wireless signalassociated with at least one of the moving the locking member or themoving the actuator.
 2. The method of claim 1, wherein: the medicalinjector includes a medicament container within the housing; the outputdevice is a speaker disposed within the housing; and the protrusionactuates the electronic circuit system when the distal end portion ofthe medical injector is removed from the outer case to cause theelectronic circuit system to produce the first output via the speaker.3. The method of claim 1, wherein: the medical injector includes amedicament container within the housing, the housing defining a statusaperture aligned with the medicament container; and the outer casesurrounds the housing of the medical injector such that the statusaperture is obstructed when the distal end portion of the medicalinjector is within the outer case, the medicament within the medicamentcontainer being visible via the status aperture after the removing thedistal end portion of the medical injector from within the outer case.4. The method of claim 1, wherein the medical injector includes amedicament container within the housing, the housing defining a statusaperture aligned with the medicament container, the outer casesurrounding the housing of the medical injector such that the statusaperture is obstructed when the distal end portion of the medicalinjector is within the outer case, the method further comprising:viewing, after the removing, the medicament via the status aperture. 5.The method of claim 1, wherein: the medical injector includes amedicament container within the housing, a needle, and a needle sheath,the medicament container placed in fluid communication with the needlein response to the moving the actuator to initiate delivery of themedicament from the medical injector, the needle sheath disposed aboutthe needle before the moving the actuator; and the removing the distalend portion of the medical injector from within the outer case isperformed while maintaining the needle sheath about the needle.
 6. Themethod of claim 1, further comprising: replacing the distal end portionof the medical injector inside the outer case.
 7. The method of claim 1,wherein the first output is a recorded speech output indicating anexpiration date of the medicament.
 8. The method of claim 1, wherein:the wireless signal is a first wireless signal; the remote device is acell phone; and the network interface device is configured to receive asecond wireless signal from the cell phone, the second wireless signalincluding information associated with the medical injector.
 9. Themethod of claim 1, wherein the second output is a recorded speech outputincluding a countdown timer.
 10. The method of claim 1, wherein thesecond output is a recorded speech output providing a post-injectiondisposal procedure.
 11. The method of claim 1, wherein the wirelesssignal is associated with the moving the actuator and includesinformation confirming that an injection operation is complete.
 12. Themethod of claim 1, wherein the medical injector is an autoinjector andthe medicament is epinephrine.
 13. A method, comprising: removing an endportion of a medical injector from within an outer case, the medicalinjector including a housing, a medicament container within the housing,a needle, a needle sheath, and an electronic circuit system, the needlesheath disposed about the needle to maintain the needle within a sterilefield, the sterile field being maintained after the removing the endportion of the medical injector from within the outer case, theelectronic circuit system including an output device and a networkinterface device, the electronic circuit system producing a first outputvia the output device in response to the removing the end portion of themedical injector from within the outer case; removing a locking memberfrom the medical injector to enable actuation of the medical injector, afirst portion of the locking member coupled to the needle sheath suchthat the needle sheath is removed from about the needle when the lockingmember is removed, a second portion of the locking member engaging theelectronic circuit system such that the electronic circuit systemproduces a second output via the output device in response to theremoving the locking member; and actuating the medical injector toinitiate delivery of a medicament from the medicament container, theelectronic circuit system producing a second output via the outputdevice in response to the actuating, the network interface devicetransmitting a wireless signal to a remote device, the wireless signalassociated with at least one of the removing the locking member or theactuating the medical injector.
 14. The method of claim 13, wherein: theoutput device is a speaker disposed within the housing of the medicalinjector; and the outer case includes a protrusion disposed within thehousing when the end portion of the medical injector is within the outercase, the protrusion actuating the electronic circuit system when theend portion of the medical injector is removed from within the outercase to cause the electronic circuit system to produce the first outputvia the output device.
 15. The method of claim 13, wherein: the housingof the medical injector defines a status aperture aligned with themedicament container; and the outer case surrounds the housing of themedical injector such that the status aperture is obstructed when theend portion of the medical injector is within the outer case, themedicament within the medicament container being visible via the statusaperture after the removing the end portion of the medical injector fromwithin the outer case.
 16. The method of claim 13, wherein: theactuating includes moving an actuator coupled to the housing; and thewireless signal is associated with the moving the actuator and includesinformation confirming that an injection operation is complete.
 17. Themethod of claim 13, wherein the medical injector is an autoinjector andthe medicament container contains epinephrine.
 18. A method, comprising:removing a distal end portion of a medical injector from within an outercase, the medical injector including an actuator, a locking member, andan electronic circuit system, the outer case covering the actuator whenthe distal end portion of the medical injector is within the outer case,a portion of the outer case engaging the electronic circuit system whenthe distal end portion of the medical injector is within the outer case,the portion of the outer case spaced apart from the electronic circuitsystem when the distal end portion of the medical injector is outside ofthe outer case, the locking member in contact with the actuator to limitmovement of the actuator when the locking member is in a first position,the electronic circuit system including an output device and a networkinterface device, the electronic circuit system producing a first outputvia the output device in response to the portion of the outer case beingspaced apart from the electronic circuit system by the removing thedistal end portion of the medical injector from within the outer case;moving the locking member from the first position to a second position,the locking member spaced apart from the actuator when the lockingmember is in the second position; and moving the actuator to initiatedelivery of a medicament from the medical injector, the electroniccircuit system producing a second output via the output device inresponse to the moving the actuator, the network interface devicetransmitting a wireless signal to a remote device, the wireless signalassociated with at least one of the moving the locking member or themoving the actuator.
 19. The method of claim 18, wherein: the medicalinjector includes a housing and a medicament container within thehousing, the housing defining a status aperture aligned with themedicament container; and the outer case surrounds the housing of themedical injector such that the status aperture is obstructed when thedistal end portion of the medical injector is within the outer case, themedicament within the medicament container being visible via the statusaperture after the removing the distal end portion of the medicalinjector from within the outer case.
 20. The method of claim 18,wherein: the wireless signal is a first wireless signal; the remotedevice is a cell phone; and the network interface device is configuredto receive a second wireless signal from the cell phone, the secondwireless signal including information associated with the medicalinjector.
 21. The method of claim 18, wherein: the medical injectorincludes a housing, a medicament container within the housing, a needle,and a needle sheath, the medicament container placed in fluidcommunication with the needle in response to the moving the actuator todeliver the medicament from the medical injector, the needle sheathdisposed about the needle before the moving the actuator; and theremoving the distal end portion of the medical injector from within theouter case is performed while maintaining the needle sheath about theneedle.
 22. The method of claim 18, wherein the medical injector is anautoinjector and the medicament is epinephrine.
 23. The method of claim18, further comprising: replacing the distal end portion of the medicalinjector inside the outer case.